[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peripheral-artery-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peripheral-artery-disease":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,52,0,25,[9,49,77,102,128,158,184,207,234,256,279,302,329,352,376,401,426,445,470,492,521,550,571,595,619],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100641711","home-based-exercise-therapy-in-patients-with-moderate-to-severe-peripheral-artery-disease-100641711",false,"NCT07655206","Home-based Exercise Therapy in Patients With Moderate to Severe Peripheral Artery Disease","Effectiveness of a Home-based Cardiovascular Rehabilitation Program Compared With Standard Care in Patients With Moderate to Severe Peripheral Artery Disease: a Pilot Randomized Controlled Trial (PILOT-PAD-CYCLE)","PILOT-PADCYCLE","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Moderate-to-severe peripheral arterial disease defined by at least one of the following:\n\nABI \\\u003C 0.6 Ankle systolic pressure \\\u003C 70 mmHg Toe systolic pressure \\\u003C 40 mmHg Toe-brachial index \\\u003C 0.4\n\n* With or without lower limb wound\n* Declined referral to an in-person supervised exercise therapy program\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Lower limb revascularization within the previous 30 days\n* Planned revascularization during the first 12 weeks of the study\n* Unable to use a portable pedal exerciser\n* Unable to perform a 6-minute walk test\n* Medically unstable according to the treating clinical or rehabilitation team\n* Participation in a cardiovascular rehabilitation program within the previous year","ALL","18 Years",{"count":21,"type":22},12,"ESTIMATED","INTERVENTIONAL",[25],"NA","Peripheral arterial disease (PAD) is a chronic atherosclerotic condition associated with impaired mobility, reduced quality of life, cardiovascular events, and risk of lower limb amputation. Although supervised exercise therapy (SET) is recommended for symptomatic PAD, access and adherence remain limited, particularly among patients with moderate-to-severe disease or chronic limb-threatening ischemia (CLTI).\n\nThe PILOT-PAD-CYCLE study is a prospective, single-center, pilot randomized controlled trial designed to evaluate the feasibility, acceptability, and preliminary efficacy of a 12-week home-based exercise therapy (HET) program using a portable pedal exerciser in adults with moderate-to-severe PAD, including CLTI, with or without foot wounds.\n\nTwelve participants will be randomized 1:1 to either HET plus standard care or standard care alone. The intervention includes individualized exercise prescription, remote supervision by a kinesiologist, cardiovascular education, and follow-up over 12 weeks. Outcomes include feasibility and acceptability metrics, 6-minute walk test distance, vascular perfusion indices, quality of life, and cardiovascular events up to 6 months.\n\nThis pilot trial aims to generate feasibility data and preliminary efficacy estimates to support the development of a future multicenter randomized controlled trial.",[28],"Peripheral Artery Disease",[28,30,31,32,33,34,35,36],"Chronic Limb-Threatening Ischemia","Home-Based Exercise Therapy","Cardiovascular Rehabilitation","Pedal Exerciser","Peripheral Vascular Disease","Exercise Therapy","Randomized Controlled Trial","RECRUITING","2026-06-23",{"date":40,"type":41},"2026-06-26","ACTUAL",{"date":38,"type":41},{"date":44,"type":22},"2027-05-01",{"name":46,"class":47},"Laval University","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":18,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":48},"100540630","early-phase-1-impact-of-nrf2-activation-on-macrovascular-microvascular--leg-function--walking-capacity-in-peripheral-artery-disease-100540630","NCT06319339","Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease","Impact of Nrf2 Activation on Macrovascular Function, Microvascular Function, Leg Function, and Walking Capacity in Patients With Peripheral Artery Disease","Inclusion Criteria:\n\nPeripheral artery disease (PAD) participants:\n\n* Able to provide written informed consent\n* 50-75 years of age\n* Diagnosed as Fontaine stage II-III\n* History of exercise-induced claudication\n* Females must be postmenopausal (cessation of menses for \\> 24 months)\n* Normal renal function (serum creatinine-estimated glomerular filtration rate \\>= 60 mL\u002Fmin) or evidence of stable renal function within the last 6 months\n* Normal hepatic function (alanine transaminase \\\u003C 87.5 U\u002FL, alkaline phosphatase \\\u003C 260 U\u002FL, total bilirubin 1.8 mg\u002FdL) or evidence of stable hepatic function within the last 6 months\n* Complete blood count:\n\n  * Females: red blood cell 4-5 trillion cells\u002FL, hemoglobin 12-15 g\u002FdL, hematocrit 34-45%, white blood cell count 3-10 billion cells\u002FL, platelet count 160-380 billion\u002FL, and normal lymphocyte count \\> 700 million lymphocytes\u002FL, or evidence of stable blood counts within the last 6 months\n  * Males: red blood cell 4-6 trillion cells\u002FL, hemoglobin 13-17 g\u002FdL, hematocrit 38-49%, white blood cell count 3-10 billion cells\u002FL, platelet count 135-320 billion\u002FL, and normal lymphocyte count \\> 700 million lymphocytes\u002FL, or evidence of stable blood counts within the last 6 months\n\nAge-matched control participants:\n\n* Able to provide written informed consent\n* 50-75 years of age\n* No evidence of peripheral occlusive disease (ankle-brachial index \\> 0.90)\n* Females must be postmenopausal (cessation of menses for \\> 24 months)\n* Normal renal function (serum creatinine-estimated glomerular filtration rate \\>= 60 mL\u002Fmin), or evidence of stable renal function within the last 6 months\n* Normal hepatic function (alanine transaminase \\\u003C 87.5 U\u002FL, alkaline phosphatase \\\u003C 260 U\u002FL, total bilirubin 1.8 mg\u002FdL ), or evidence of stable hepatic function within the last 6 months\n* Complete blood count:\n\n  * Females: red blood cell 4-5 trillion cells\u002FL, hemoglobin 12-15 g\u002FdL, hematocrit 34-45%, white blood cell count 3-10 billion cells\u002FL, platelet count 160-380 billion\u002FL, and normal lymphocyte count \\> 700 million lymphocytes\u002FL\n  * Males: red blood cell 4-6 trillion cells\u002FL, hemoglobin 13-17 g\u002FdL, hematocrit 38-49%, white blood cell count 3-10 billion cells\u002FL, platelet count 135-320 billion\u002FL, and normal lymphocyte count \\> 700 million lymphocytes\u002FL, or evidence of stable blood counts within the last 6 months\n\nExclusion Criteria:\n\nPeripheral artery disease (PAD) participants:\n\n* • Pain at rest and\u002For tissue loss due to PAD (Fontaine stage IV PAD)\n* Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma\n* Limited walking capacity from conditions other than PAD\n* No physical exam to assess exercise limitations in the past year\n* Currently pregnant or nursing\n* Blood work and medical history NOT demonstrating:\n\n  * Normal renal function (serum creatinine-estimated glomerular filtration rate \\>\\> 60 mL\u002Fmin)\n  * Normal hepatic function (alanine transaminase 0-35 IU\u002FL, alkaline phosphatase 30-120 IU\u002FL, total bilirubin 2-17 micromoles\u002FL),\n* Diagnosis of multiple sclerosis or psoriasis\n* Diagnosis of gastrointestinal disorders (e.g., moderate IBS, Crohn's disease, etc.\n* Concomitant use of dimethyl fumarate\n* Hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY\n* Ulcers, gangrene, or necrosis of the foot (Fontaine stage IV PAD)\n* Complete blood count NOT within ranges:\n\n  * Females: red blood cell 4-5 trillion cells\u002FL, hemoglobin 12-15 g\u002FdL, hematocrit 34-45%, white blood cell count 3-10 billion cells\u002FL, platelet count 160-380 billion\u002FL, and normal lymphocyte count 1-4.8 billion lymphocytes\u002FL\n  * Males: red blood cell 4-6 trillion cells\u002FL, hemoglobin 13-17 g\u002FdL, hematocrit 38-49%, white blood cell count 3-10 billion cells\u002FL, platelet count 135-320 billion\u002FL, and normal lymphocyte count 1-4.8 billion lymphocytes\u002FL\n\nAge-matched control participants:\n\n* Positive diagnosis of PAD\n* No physical exam to assess exercise limitations in the past year\n* Any exercise limitations as determined at last physical exam\n* Limited walking capacity from musculoskeletal injury\n* Currently pregnant or nursing\n* Renal function not within normal ranges (serum creatinine-estimated glomerular filtration rate \\>\\> 60 mL\u002Fmin)\n* Hepatic function not within normal ranges (alanine transaminase 0-35 IU\u002FL, alkaline phosphatase 30-120 IU\u002FL, total bilirubin 2-17 micromoles\u002FL)\n* Complete blood count NOT within ranges:\n\n  * Females: red blood cell 4-5 trillion cells\u002FL, hemoglobin 12-15 g\u002FdL, hematocrit 34-45%, white blood cell count 3-10 billion cells\u002FL, platelet count 160-380 billion\u002FL, and normal lymphocyte count 1-4.8 billion lymphocytes\u002FL\n  * Males: red blood cell 4-6 trillion cells\u002FL, hemoglobin 13-17 g\u002FdL, hematocrit 38-49%, white blood cell count 3-10 billion cells\u002FL, platelet count 135-320 billion\u002FL, and normal lymphocyte count 1-4.8 billion lymphocytes\u002FL",true,"50 Years","75 Years",{"count":60,"type":22},20,[62],"EARLY_PHASE1","Peripheral artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exercise, thereby implicating impaired endothelial function as a mechanism contributing to exacerbated exercise-induced ischemia. Therefore, the purpose of this study is to test the hypothesis that acute exogenous diroximel fumarate (Vumerity) intake will improve antioxidant capacity, thereby reducing oxidative stress and improving vascular function and walking capacity in those with PAD. During this study, participants will be administered diroximel fumarate or a placebo, and the acute effects of diroximel fumarate on vascular function and walking capacity will be assessed. Vascular function and walking capacity will be assessed with flow-mediated dilation, arterial stiffness, head-up tilt test, blood biomarkers, near-infrared spectroscopy, and a treadmill test. There will be a follow-up visit to assess blood work after diroximel fumarate.",[28,65,66,67],"Peripheral Vascular Diseases","Peripheral Arterial Disease","Peripheral Arterial Occlusive Disease","2026-06-19",{"date":70,"type":41},"2026-06-24",{"date":72,"type":41},"2024-11-14",{"date":74,"type":22},"2026-12",{"name":76,"class":47},"University of Nebraska",{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":48},"100539177","randomized-controlled-trial-of-alert-based-computerized-decision-support-for-patients-with-peripheral-artery-disease-not-prescribed-lipid-lowering-therapy-100539177","NCT06300450","Randomized Controlled Trial of Alert-Based Computerized Decision Support for Patients With Peripheral Artery Disease Not Prescribed Lipid-Lowering Therapy","PAD-ALERT","Inclusion Criteria:\n\n* All patients ≥ 18 years old\n* Seen in Cardiovascular Medicine Clinic, Primary Care, Podiatry, Vascular Surgery, and Diabetology\n* Medical history entry, visit diagnosis, or problem list entry of PAD\n* Not prescribed LDL-C-lowering therapy\n\nExclusion Criteria:\n\n* Patients taking a statin, ezetimibe, bempedoic acid, a PCSK9 inhibitor, inclisiran or a combination will be excluded",{"count":85,"type":22},400,[25],"This single-center, 400-patient, randomized controlled trial assesses the impact of a patient- and provider-facing EPIC Best Practice Advisory (BPA; alert-based computerized decision support tool) to increase guideline-directed utilization of statin and statin-alternative oral LDL-C lowering therapies in patients with PAD who are not being prescribed LDL-C-lowering therapy.",[28,65,89],"Dyslipidemias",[91,28,34,92],"Dyslipidemia","Computerized Decision Support","2026-06-16",{"date":95,"type":41},"2026-06-17",{"date":97,"type":41},"2023-03-01",{"date":99,"type":22},"2026-12-30",{"name":101,"class":47},"Brigham and Women's Hospital",{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":48},"100614722","prevalence-of-obstructive-sleep-apnea-in-patients-with-peripheral-arterial-occlusive-disease-100614722","NCT07283289","Prevalence of Obstructive Sleep Apnea in Patients With Peripheral Arterial Occlusive Disease","Prospective Observational Cohort Study on the Prevalence of Obstructive Sleep Apnea in Patients With Peripheral Arterial Occlusive Disease","OSAPAD","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients with a confirmed diagnosis of PAOD, seen either during hospitalization or in an outpatient vascular medicine consultation. Inclusion is permitted regardless of the disease stage (according to the Leriche and Fontaine classification) or prior surgical intervention.\n3. No objection to the use of their pseudonymised medical data\n4. Polygraphy scheduled as part of routine care within one month.\n\nExclusion Criteria:\n\n1. Inability to perform the Ankle-Brachial Index (ABI) or sleep polygraphy due to physical or cognitive constraints (e.g., severe dementia, limb malformation, etc.).\n2. History of OSAS diagnosis confirmed by polygraphy, and currently receiving nocturnal treatment (e.g., Continuous Positive Airway Pressure - CPAP)",{"count":111,"type":22},295,"OBSERVATIONAL","Obstructive sleep apnea syndrome (OSAS) is characterized by partial (hypopnea) or complete (apnea) obstruction of the upper airways, leading to intermittent hypoxemia and sleep fragmentation. Peripheral arterial occlusive disease (PAOD) is a chronic condition defined by the narrowing or occlusion of arteries in the lower limbs, often resulting in ischemia of downstream tissues. This disease is a common complication of atherosclerosis and affects approximately 1.2% of the general French population.\n\nOSAS is a well-established risk factor for atherosclerotic disease, particularly for coronary and neurovascular events. Although a relationship between OSAS and PAOD has been investigated in recent years, the link has not been definitively established and requires further study. Therefore, this preliminary cohort study aims to observe the prevalence of OSAS among patients diagnosed with PAOD, regardless of the disease stage.",[28],[116,117,118,119,67],"Obstructive Sleep Apnea Syndrome","Polygraphy","Diagnosis","Prevalence","2026-06-15",{"date":93,"type":41},{"date":123,"type":41},"2025-11-05",{"date":125,"type":22},"2026-11",{"name":127,"class":47},"Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer",{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":144,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":48},"100540586","predictive-value-of-systolic-rise-time-of-the-plantar-arch-on-the-risk-of-major-adverse-limb-events-male-and-major-adverse-cardiovascular-events-mace-in-peripheral-artery-disease-pad-at-critical-ischaemia-stage-100540586","NCT06318767","Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) in Peripheral Artery Disease (PAD) at Critical Ischaemia Stage","TAMIS","Inclusion Criteria:\n\n* patients at least 18 years old,\n* willing and able to provide written informed consent,\n* with documented atherosclerosis critical limb ischemia (pain rest and\u002For ulcer and gangrene manifestations)\n* with hemodynamic measures (ankle pressure less than 50mmHg and\u002For TBI less than 30mmHg and\u002For TcPO2 less than 30 mmHg),\n* followed or send to CHU Amiens Picardie, and eligible to chirurgical revascularization.\n\nExclusion Criteria:\n\n* with non atherosclerosis arteriopathy,\n* ineligible to the gold standard treatment such as the chirurgical revascularization,\n* with life expectancy less than 3 months.",{"count":136,"type":22},134,[25],"Peripheral artery disease (PAD), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades. It has various symptoms ranging from mild arterial claudication to critical limb ischemia. The critical ischaemia stage in PAD is defined by rest pain or trophic disorders and is a special situation because of the number of cardiovascular deaths at 1 year (25%), 60% at 5 years and acute ischaemic recurrence at 1 year (25%).\n\nIt is a medico-surgical pathology. A haemodynamic marker is needed to monitor patients, as it is predictive of limb progression, cardiovascular events and mortality. The Systolic Rise Time (SRT) of the plantar footpad is a recently described haemodynamic measurement of proven value in the diagnosis of PAD. The aim of this study is to show the prognostic value of the Systolic Rise Time on Major Adverse Limb Events (MALE).",[140,141,28,142,143],"Major Adverse Limb Events","Major Adverse Cardiovascular Events","Critical Limb Ischemia","Hemodynamic Measure",[145,146,147,148,149],"major adverse limb events","major adverse cardiovascular events","peripheral artery disease","critical limb ischemia","hemodynamic measure","2026-06-12",{"date":120,"type":41},{"date":153,"type":41},"2024-03-07",{"date":155,"type":22},"2026-09",{"name":157,"class":47},"Centre Hospitalier Universitaire, Amiens",{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":183},"100509708","the-thor-ide-study-100509708","NCT05916950","The THOR IDE Study","THOR","Inclusion Criteria:\n\n* Patient age is ≥18 years\n* Patient agrees to participate and to comply with the protocol by signing an IRB approved patient consent form\n* Patient is able to walk unassisted or with non-motorized assistive devices\n* Patient has PAD with documented Rutherford Class 2-4 of the target limb\n* Anticipated life expectancy \\>12 months, in the opinion of the investigator at the time of enrollment.\n\nAngiographic Inclusion Criteria:\n\n* Patient has de novo atherosclerotic disease of the native SFA and\u002For the popliteal arteries\n* Target lesion has ≥70% diameter stenosis by investigator via visual assessment\n* Target lesion length ≤150mm. Total treatment zone may not exceed 150mm, and may include one or more lesions.\n* Chronic total occlusion lesion length is \\\u003C100mm of the total ≤150mm target lesion\n* Minimum reference vessel diameter (RVD) 4.0mm by visual estimate\n* Target lesion crossed and intraluminal guidewire placement confirmed; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations\n* At least one patent tibial vessel (defined as \\\u003C50% stenosis) with runoff to the foot\n* Target lesion has moderate to severe calcification graded using the Peripheral Academic Research Consortium (PARC) criteria\n\nExclusion Criteria:\n\n* Patient has active infection requiring antibiotic therapy\n* Stenting planned within the target lesion\n* Known positive for COVID-19 within the last 2 weeks and actively symptomatic\n* Pregnant (positive pregnancy test) or currently breast feeding\n* Evidence of Acute Limb Ischemia in the target limb within 7 days prior to procedure\n* Cerebrovascular accident (CVA) \\\u003C60 days prior to procedure\n* Myocardial infarction \\\u003C60 days prior to procedure\n* History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to baseline screening\n* Known contraindication to aspirin, or antiplatelet\u002Fanti-coagulant therapies required for procedure\u002Ffollow-up\n* Known allergy to contrast media that cannot adequately be premedicated prior to study procedure\n* History of Thrombophilia, Heparin-induced Thrombocytopenia (HIT), or Heparin-induced Thrombotic Thrombocytopenia Syndrome (HITTS)\n* Serum creatinine ≥2.5mg\u002FdL (unless dialysis-dependent) tested within 30 days prior to procedure\n* Planned lower limb major amputation (above the ankle)\n* Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned on target limb for within 30 days following index procedure, with the exception of diagnostic angiography\n* Currently participating in any investigational device or drug clinical trial that, in the opinion of the investigator, will interfere with the conduct of the current study\n* The use of specialty balloons, re-entry or additional atherectomy devices is required for treatment of the target lesion.\n\nAngiographic Exclusion Criteria:\n\n* Subject has significant stenosis (\\>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated.\n* Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target site at the time of the index procedure.",{"count":166,"type":22},155,[25],"The goal of this clinical trial is to test the Thor system in adult (≥ 18 year old) patients with de novo (new, never treated) calcified lesions in infrainguinal (leg) arteries (peripheral artery disease or PAD).\n\nThe main question\\[s\\] it aims to answer are:\n\n* Is the Thor system safe in treating these lesions\n* Does the Thor system work to treat these lesions\n\nParticipants will:\n\n* Receive treatment with the Thor system\n* Have follow-up visits at Discharge, 30 days, 6 months, and 12 months",[28,170,171,172],"Peripheral Artery Stenosis","Peripheral Artery Calcification","PAD","2026-06-10",{"date":175,"type":41},"2026-06-11",{"date":177,"type":41},"2024-10-29",{"date":179,"type":22},"2027-12",{"name":181,"class":182},"Philips Clinical & Medical Affairs Global","INDUSTRY",29,{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":18,"minAge":191,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":48},"100493994","the-effects-of-a-novel-non-ischemic-and-pain-free-exercise-intervention-in-peripheral-artery-disease-100493994","NCT05712395","The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease","NICE","Inclusion Criteria:\n\n1. history of claudication assessed by the Walking Impairment Questionnaire,\n2. ambulatory leg pain in either one or both legs consistent with intermittent claudication confirmed during a screening graded treadmill test using the Gardner-Skinner protocol,\n3. an ABI \\\u003C= 0.90 at rest or \\> 20% decrease in ankle systolic blood pressure in either one or both legs immediately following the treadmill exercise test.\n4. age \\>= 40 years.\n\nExclusion Criteria:\n\n1. absence of PAD (ABI \\> 0.90 at rest and ankle systolic blood pressure \\\u003C 20% decrease after exercise,\n2. inability to obtain an ABI measure due to non-compressible vessels (ABI \\> 1.40),\n3. asymptomatic PAD (Fontaine Stage I) determined from the medical history and verified during the graded treadmill test,\n4. rest pain due to PAD (Fontaine stage III)\n5. tissue loss due to PAD (Fontaine stage IV)\n6. use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,\n7. peripheral revascularization within one month prior to investigation, or peripheral revascularization performed during the study,\n8. exercise tolerance limited by any disease process other than PAD,\n9. active cancer,\n10. kidney failure defined as stage 5 chronic kidney disease,\n11. a calf skin fold measurement \\> 25 mm, because of potential interference with the light path of the NIRS probe from penetrating the subcutaneous tissue,\n12. pulse arterial oxygen saturation of the index finger \\\u003C 95% because of potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange, and\n13. failure to complete the baseline run-in phase within three weeks.","40 Years",{"count":193,"type":22},100,[25],"This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the Non-Ischemic Exercise (NICE) program to improve exercise and vascular outcome measures in patients with peripheral artery disease (PAD).",[197,28],"Claudication","2026-05-26",{"date":200,"type":41},"2026-05-29",{"date":202,"type":41},"2024-09-09",{"date":204,"type":22},"2029-07-31",{"name":206,"class":47},"University of Oklahoma",{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":18,"minAge":215,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":220,"conditions":221,"keywords":222,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":233},"100423490","phase-3-the-cocoa-pad-ii-trial-100423490","NCT04794530","The COCOA-PAD II Trial","COCOA Flavanols to Improve Walking Performance in PAD: the COCOA-PAD II Trial","COCOA-PAD II","Inclusion Criteria:\n\n1. Age 55 and older\n2. Presence of peripheral artery disease (PAD). PAD will be defined as either:\n\n   1. An ABI \\\u003C= 0.90 at baseline.\n   2. Vascular lab evidence of PAD (such as a toe brachial pressure \\\u003C 0.70 or an ankle brachial index less than or equal to 0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities.\n   3. An ABI of \\>0.90 and \\\u003C=1.00 who experience a a 20% or greater drop in ABI in either leg after the heel-rise test will also be included.\n\nExclusion Criteria:\n\n1. Above- or below-knee amputation\n2. Critical limb ischemia\n3. Wheelchair confinement or requiring a walker to ambulate\n4. Walking is limited by a symptom other than PAD\n5. Current foot ulcer on bottom of foot\n6. Failure to successfully complete the one-week study run-in\n7. Planned major surgery, coronary or leg revascularization during the next eight months\n8. Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months\n9. Major medical illness including lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than eight months, or cancer requiring treatment in the previous two years. \\[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who require oxygen only at night may still qualify.\\]\n10. Mini-Mental Status Examination (MMSE) score \\\u003C 23\n11. Allergy to the study intervention\n12. Potential participants who have taken cocoa supplements in previous three months, are unwilling to avoid taking cocoa flavanol supplements, or are consuming dark chocolate regularly (i.e. approximately 1.5 ounces of dark chocolate more than three times per week, or more than 4.5 ounces per week).\n13. Non-English speaking\n14. Participation in or completion of a clinical trial in the previous three months. \\[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\\]\n15. Visual impairment that limits walking ability\n16. Six-minute walk distance of \\\u003C500 feet or \\>1600 feet.\n17. Participation in a supervised treadmill exercise program in previous three months\n18. Unable to tolerate caffeine\n19. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant","55 Years",{"count":217,"type":22},190,[219],"PHASE3","Among people with peripheral artery disease (PAD) age 55 and older, the investigators will test the hypothesis that PAD participants randomized to cocoa flavanols will have greater improvement or less decline in six-minute walk distance at six-month follow-up, compared to those randomized to placebo. The study will randomize 190 participants with PAD age 55 and older to one of two groups for six months: cocoa flavanols vs placebo. Our primary outcome is change in six-minute walk distance at six-month follow-up. Secondary outcomes are Actigraph-measured physical activity, brachial artery flow-mediated dilation (FMD), gastrocnemius muscle biopsy measures of endothelial nitric oxide synthase (eNOS) and phosphorylated eNOS, gastrocnemius muscle perfusion (measured by magnetic resonance imaging (MRI)) and gastrocnemius muscle characteristics (measured by muscle biopsy).\n\nTo achieve the specific aims, the study will randomize 190 participants age 55 and older with PAD to one of two groups: cocoa flavanols vs placebo. Participants will be followed for six months.",[28],[223],"cocoa flavanols","2026-05-24",{"date":226,"type":41},"2026-05-28",{"date":228,"type":41},"2021-11-19",{"date":230,"type":22},"2027-06-01",{"name":232,"class":47},"Northwestern University",3,{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":56,"sex":18,"minAge":19,"maxAge":241,"enrollmentInfo":242,"targetDuration":244,"studyType":112,"phases":4,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":48},"100621744","the-value-of-super-resolution-ultrasound-imaging-for-peripheral-artery-disease-100621744","NCT07374601","The Value of Super-resolution Ultrasound Imaging for Peripheral Artery Disease","The Predictive Value of Super-resolution Ultrasound Microvascular Imaging for the Prognosis of Peripheral Artery Disease","\\*Inclusion Criteria:\\*\n\n1. Adults aged ≥18 years and ≤100 years;\n2. Diagnosis of peripheral artery disease (PAD) confirmed by comprehensive clinical assessment-including characteristic symptoms (e.g., intermittent claudication, rest pain), physical findings (e.g., diminished or absent distal pulses, bruits), ankle-brachial index (ABI) \\\u003C 0.9, and corroborating vascular imaging (e.g., duplex ultrasonography, CTA, or MRA);\n3. Alternatively, healthy adults without PAD (i.e., ABI ≥ 0.9, absence of suggestive symptoms or signs, and no history of atherosclerotic cardiovascular disease) who meet all other eligibility requirements;\n4. Willing and able to provide written informed consent.\n\n\\*Exclusion Criteria:\\*\n\n1. Inability to complete study procedures due to:\n\n   1. Severe involuntary movement disorders (e.g., advanced Parkinson's disease or cerebellar ataxia) interfering with image acquisition;\n   2. Contraindication to contrast-enhanced ultrasound (e.g., documented hypersensitivity to sulfur hexafluoride microbubble contrast agent \\[SonoVue®\\]);\n   3. Active lower-limb infection (e.g., diabetic foot infection with systemic signs or osteomyelitis), which precludes safe or interpretable data collection;\n2. Cognitive impairment or legal incapacity precluding autonomous informed consent;\n3. Refusal-by the participant or their legally authorized representative-to provide informed consent.","100 Years",{"count":243,"type":22},300,"300 Months","Peripheral artery disease (PAD) is a chronic atherosclerotic disorder characterized by stenosis or occlusion of the extracranial arteries distal to the aortic arch, most commonly affecting the lower extremities. This vascular compromise leads to tissue hypoperfusion, resulting in a spectrum of clinical manifestations ranging from asymptomatic disease to intermittent claudication, critical limb ischemia, and limb loss.\n\nThe microvascular system comprises arterioles, capillaries, and post-capillary venules with diameters less than or equal to 100 micrometers. Emerging evidence underscores that microvascular dysfunction (MVD)-defined as structural and functional impairment of this microcirculatory network-plays a pivotal pathophysiological role in PAD progression, contributing to impaired perfusion reserve, endothelial dysfunction, inflammation, and tissue fibrosis, independent of macrovascular stenosis severity.\n\nSuper-resolution ultrasound microvascular imaging (SRUMI) is an advanced contrast-enhanced ultrasound technique that leverages the nonlinear acoustic signatures of intravascular microbubble contrast agents (e.g., SonoVue) under ultra-low mechanical index (MI) pulsing schemes. Implemented on the Verasonics Vantage 256 research platform (Verasonics, Inc., Kirkland, WA, USA), SRUMI achieves in vivo visualization of microvascular architecture at sub-diffraction resolution (approximately 10-20 micrometers), surpassing conventional Doppler and contrast-enhanced ultrasound. Key advantages include absence of ionizing radiation, negligible thermal and mechanical bioeffects, real-time capability, portability, and cost-effectiveness. As such, SRUMI represents a promising noninvasive tool to probe microvascular integrity in PAD, enabling mechanistic investigation of MVD's contribution to disease initiation, progression, and therapeutic response.\n\nThis study aims to evaluate the diagnostic and prognostic utility of SRUMI for assessing microvascular dysfunction in patients with PAD. The investigators prospectively enrolled patients diagnosed with PAD and admitted to the Department of Interventional Vascular Surgery at Peking University First Hospital. Primary objectives include:\n\nCharacterizing lower-limb microvascular density, morphology, and perfusion patterns via SRUMI across PAD subgroups stratified by comorbidities-including diabetes mellitus, current or former smoking, hypertension, and chronic kidney disease;\n\nAssessing the concordance between SRUMI-derived microvascular parameters and established clinical and paraclinical markers, including symptom severity (Rutherford classification), ankle-brachial index (ABI), urinary albumin-to-creatinine ratio (UACR), and retinal microvascular findings on fundoscopy;\n\nDetermining the sensitivity, specificity, and predictive value of baseline SRUMI metrics for major adverse limb events (MALE) and cardiovascular outcomes during longitudinal follow-up; and\n\nComparing the incremental prognostic value of SRUMI against conventional modalities-including ABI, duplex ultrasonography, and clinical risk scores-using multivariable Cox regression and time-dependent receiver operating characteristic (ROC) analyses.\n\nCollectively, this research seeks to establish SRUMI as a quantitative, translatable biomarker of microvascular health in PAD, thereby advancing precision phenotyping, risk stratification, and monitoring of therapeutic efficacy in this high-morbidity population.",[28],"2026-05-14",{"date":249,"type":41},"2026-05-18",{"date":251,"type":41},"2026-02-08",{"date":253,"type":22},"2028-12-31",{"name":255,"class":47},"Peking University First Hospital",{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":278},"100380083","promote-weight-loss-in-obese-peripheral-artery-disease-pad-patients-to-prevent-mobility-loss-100380083","NCT04228978","Promote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to Prevent Mobility Loss","PROmote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to preVEnt Mobility Loss: The PROVE Trial","PROVE","Inclusion criteria are a) presence of PAD; b) BMI\\> 25 kg\u002Fm2; c) Age \\>= 18. The diagnosis of PAD will be based on the following. First, an ankle brachial index (ABI) value \\\u003C= 0.90, which is a well-accepted standard for diagnosing PAD. People with a toe brachial index of \\\u003C=0.70, performed at the study visit, will be eligible. Second, people with an ABI of \\>0.90 and \\\u003C=1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test will also be included. Third, potential participants with an ABI \\> 0.90 who provide vascular laboratory evidence or angiographic evidence of PAD will be included. Prior vascular laboratory evidence consists of objective evidence of PAD including toe brachial index (TBI) \\\u003C 0.70, Duplex measure showing 70% stenosis or greater, a post-exercise ABI drop in either leg of 20% or greater, or ABI values \\\u003C= 0.90. Angiographic evidence of PAD consists of a stenosis of 70% or greater in a lower extremity artery. Fourth, people with a history of lower extremity revascularization who do not meet the criterion above and have an ABI \\> 0.90 with a 20% or higher drop in ABI after an exercise test will be eligible if they have symptomatic PAD. Symptomatic PAD will be defined as leg symptoms associated with exertion that resolved within 10 minutes of rest. The presence of symptomatic PAD will be determined based on the claudication questionnaire, the six-minute walk, or principal investigator interview\u002Fdiscussion with the potential participant. The post-exercise ABI drop will be measured by obtaining an ABI, having the participant exercise, and then immediately repeating the ABI. The exercise may consist of either the six-minute walk test or the heel-rise test. The heel-rise test consists of 50 heel rises at a rate of one per second. From the beginning of the trial until early 2023, we used the BMI inclusion criterion of \\> 28 kg\u002Fm2 because overweight and obesity are defined as a BMI of 25 to 29 kg\u002Fm2 and \\> 30 kg\u002Fm2, respectively, and because in our PAD cohorts, those with BMI \\> 28 kg\u002Fm2 have significantly greater functional impairment and faster functional decline than those with BMI of 20-28 kg\u002Fm2. In order to increase the rate of recruitment, on 1\u002F19\u002F2022, investigators reduced the BMI inclusion criterion to \\> 25 kg\u002F m2. People with BMI above 25 are overweight or obese and therefore are expected to benefit from the healthy lifestyle intervention.\n\nExclusion Criteria:\n\n1. Above or below knee amputation, critical limb ischemia, or wheelchair confinement.\n2. Walking is limited by a condition other than PAD.\n3. Failure to complete the study run-in, defined as not entering at least 800 Kcal of consumed calories per day for at least five days during the 14-day run-in\\*.\n4. Major surgery, coronary or leg revascularization in the past 3 months or anticipated in the next year.\n5. Experienced a heart attack or stroke in the past 3 months.\n6. Major medical illness including lung disease requiring oxygen or life-threatening illness, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. \\[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent.\n7. Mini-Mental Status Examination (MMSE) score \\\u003C 23, dementia and substance abuse. Potential participants with an MMSE score of less than 23 may be eligible if the principal investigator determines that their lower score is due to reasons other than poor cognition. Other potential reasons for lower scores include poor literacy or that English is not their first language.\n8. History of being treated for new onset or an acute episode of schizophrenia or psychosis in the past 6 months.\n9. Hospitalization for a psychiatric disorder in the past 6 months.\n10. BMI \\> 45 kg\u002Fm2\n11. History of a significant eating disorder that has been active within the past 5 years or any weight loss treatment in the past 6 months. Weight loss treatment includes weight watchers, any history of weight loss surgery, and using weight loss medications now or in the past six months.\n12. Weight gain or loss of more than 25 pounds in the past six months\n13. Potential participants unwilling\u002Funable to use a smart phone and unwilling to attend weekly study sessions.\n14. Excessive alcohol use, defined as \\>14 drinks\u002Fweek in men and \\> 10 alcoholic drinks\u002Fweek in women.\n15. Current ulcer on bottom of foot\n16. Current participation in supervised treadmill exercise, participation in supervised treadmill exercise in the past three months, or planning to participate in supervised treadmill exercise in the next year\n17. Increase in angina or angina at rest. Potential participants may become eligible following an abnormal baseline treadmill stress test if they have evidence of an absence of coronary ischemia based on testing with their own physician.\n18. Non-English speaking\n19. Visual impairment that limits walking ability\n20. Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention\n21. Participation in or completion of a clinical trial in the previous three months. \\[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\\]\n22. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant",{"count":265,"type":22},212,[25],"The PROVE Trial is a randomized clinical trial that will determine whether a weight loss intervention combined with walking exercise achieves greater improvement or less decline in six-minute walk distance at 12 month follow-up than walking exercise alone in people with PAD and BMI\\>25 kg\u002Fm2. The intervention uses a Group Mediated Cognitive Behavioral framework, connective mobile technology, remote monitoring by a coach, and a calorie restricted Dietary Approaches to Stop Hypertension (DASH)-derived Optimal Macronutrient Intake Trial for Heart Health (OMNIHeart) diet.\n\n212 participants with PAD and BMI \\> 25 kg\u002Fm2 will be randomized to one of two groups: weight loss + exercise (WL+EX) vs. exercise alone (EX). Participants will be randomized at Northwestern, Tulane University, and University of Minnesota. Our primary outcome is change in six-minute walk distance at 12-month follow-up. Secondary outcomes are change in 6-minute walk distance at 6-month follow-up and change in exercise adherence, physical activity, patient-reported walking ability (measured by the Walking Impairment Questionnaire (WIQ) distance score), and mobility (measured by the Patient-Reported Outcomes Measurement Information System \\[PROMIS\\] mobility questionnaire) at 12-month follow-up. Tertiary outcomes are perceived exertional effort (measured by the Borg scale at the end of the 6-minute walk at 12-month follow-up), and diet quality. Exploratory outcomes consist of change in the short physical performance battery (SPPB), the WIQ stair climbing and walking speed scores, and calf muscle biopsy measures at 12-month follow-up. Study investigators will perform calf muscle biopsies in 50 participants to compare changes in mitochondrial biogenesis and activity, capillary density, and inflammation between WL+EX vs. EX.",[28,269],"Overweight or Obesity","2026-05-05",{"date":272,"type":41},"2026-05-07",{"date":274,"type":41},"2020-03-01",{"date":276,"type":22},"2027-08-01",{"name":232,"class":47},7,{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":292,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":4},"100639744","revascularization-with-modification-using-definitive-ivl-and-serration-remodeling-for-optimal-lumen-100639744","NCT07575568","Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen","REMODEL I: Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen","REMODEL I","\\*Inclusion Criteria for Cohort A: ATK arm of the study:\n\nClinical:\n\n* Subject is ≥ 18 years of age\n* Target limb is Rutherford Clinical Category 2, 3 or 4\n* Resting ABI of ≤0.90, or TBI ≤0.70 of the target limb\n\nAngiographic:\n\n* Subject must have a de novo target lesion in a native superficial femoral artery (SFA) or popliteal artery\n* Reference vessel diameter (RVD) between 4.0 and 8.0mm\n* Target lesion must have a diameter stenosis of ≥70%\n* Lesion calcification is at least moderate\n* Total planned target lesion length must be ≤150mm\n* Chronic total occlusion lesion length is ≤100mm\n* Subject has at least one patent tibial vessel on the target limb with runoff to the foot\n\n  * Exclusion Criteria for Cohort A: ATK arm of the study:\n\nClinical:\n\n* Rutherford Clinical Categories 0, 1, 5 and 6\n* Subject with known pregnancy or is nursing\n* Subject has acute or chronic renal disease, defined as serum creatinine of \\>2.5 mg\u002FdL or \\>220 µmol\u002FL or on dialysis\n\nAngiographic:\n\n* Target lesions \\>150mm by visual estimation\n* Chronic total occlusions \\> 100mm by visual estimation\n* No or mild calcium present in the target lesion\n\n  * Inclusion Criteria for Cohort B: BTK arm of the study:\n\nClinical:\n\n* Age of subject is ≥18\n* Rutherford Clinical Category 2 - 5 (with tissue loss limited to the digits and no evidence of infection)\n\nAngiographic:\n\n* Single or two target lesion(s) located in a de novo artery distal to the trifurcation vessels\n* Target vessel reference diameter is between 2.5mm and 4.0 mm\n* Target lesion with diameter stenosis ≥50%\n* Target lesion is ≤150mm in length\n* Subject has at least one patent tibial vessel (\\>50%) with run-off to the foot.\n* Calcification is at least moderate\n\n  * Exclusion Criteria for Cohort B: BTK arm of the study:\n\nClinical:\n\n* Rutherford Clinical Category 0,1 or 6\n* Gangrene of the lower extremity\n* Patient is pregnant or nursing\n\nAngiographic:\n\n* Target lesion is within only lower extremity vessel with \\\u003C 50% stenosis\n* Target lesion length exceeds 150mm\n* Patient has chronic total occlusion of target lesion",{"count":288,"type":22},30,[25],"The objective of this first-in-human study is to assess the safety and effectiveness of the Serranator Sonic Intravascular Lithotripsy (IVL) System™ for the treatment of peripheral artery disease.",[28],"NOT_YET_RECRUITING","2026-05-04",{"date":295,"type":41},"2026-05-08",{"date":297,"type":22},"2026-05",{"date":299,"type":22},"2027-09",{"name":301,"class":182},"Cagent Vascular LLC",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":18,"minAge":310,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":316,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":233},"100518698","telehealth-delivered-home-based-walking-for-vets-with-peripheral-artery-disease-100518698","NCT06033924","Telehealth Delivered Home-based Walking for Vets With Peripheral Artery Disease","Telehealth Delivered Home-based Walking for Vets With Peripheral Artery Disease (TREK-PAD)","TREK-PAD","Inclusion Criteria:\n\n* Men and women\n* Diagnosis of lower extremity PAD due to atherosclerosis\n* Claudication with walking defined as stage 1-3 on the Rutherford Scale\n* Medical clearance from the patient's primary care provider or vascular care provider\n* Ability to walk at least one city block\n* Self-reported sedentary behaviors defined as \\\u003C 150 minutes per week of physical activity\n* Access to a phone and\u002For email \\& Internet\n* Competent to provide informed consent\n\nExclusion Criteria:\n\n* Life expectancy of less than six months\n* Comorbidities that limit walking to a severe degree (i.e., wheelchair-bound)\n* Resident of a nursing home\n* Recent enrollment in an exercise program or performing 150 minutes per week or more of exercise\n* Planned revascularization or amputation in the next two months\n* Recent CVD events (\\\u003C 3 months) including stroke\u002FTIA, MI, UA, PCI\u002FCABG\n* Unstable cardiac conditions (severe valve disease, NYHA class III-IV heart failure, untreated complex congenital heart disease, or complex arrhythmias)\n* Current substance abuse\n* Psychiatric disorder which limits the patient's ability to follow the study protocol\n* Pregnancy\n* Inability to speak and read English","21 Years",{"count":312,"type":22},225,[25],"Walking is beneficial for adults with peripheral arterial disease. Benefits include the ability to walk for longer periods and general well being (quality of life). This study will look at two types of delivery methods for a home-based walking program. The walking program includes step count goals, information on healthy walking and motivational messages. The two delivery methods include a web-based delivery and an telehealth delivery. Participants are randomized to either one of the delivery methods or usual care. After 12 weeks participants in the web based or telehealth based groups maybe re-randomized to receive a combination of both web-based and telehealth for a second 12 week period. After 24 weeks, everyone is followed for an additional 12 weeks, so the total time a participant is in the study is 36 weeks. At baseline, 12, 24 and 36 weeks the investigators ask participant to walk (slowly) on a treadmill, perform a six-minute walk test, and several questionnaires on quality of life. Vouchers are provided at each study visit. All participants who complete the study also keep their pedometer.",[28],[147,317,318],"physical activity","quality of life","2026-04-30",{"date":321,"type":41},"2026-05-06",{"date":323,"type":41},"2024-07-01",{"date":325,"type":22},"2027-10-29",{"name":327,"class":328},"VA Office of Research and Development","FED",{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":233},"100346533","stents-post-dilation-with-dcb-or-poba-in-femoropopliteal-arteries-100346533","NCT03791970","Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries","A Prospective, Single Center, Case-cohort Study Using the Orchid Drug Coated Balloon for Post-Dilatation of the Stent for Treatment of Long Lesions in Femoropopliteal Arteries","SFPA","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. The subject is legally competent and able to understand the information on the study, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF);\n3. Rutherford Category 2-4;\n4. Target de novo lesion(s) or non-stented restenotic lesion(s) has angiographic evidence of long-term occlusion (by visual estimate ≥10cm) and is amenable to treatment with stents placement;\n5. Patients must be able to be treated with DCB or POBA for post-dilation;\n6. Target vessel reference diameter is 4.0-7.0 mm (by visual estimate) and able to be treated with available device size matrix;\n7. At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with stents placement).\n8. No other prior vascular interventions (including contralateral limb) within 2 weeks before and\u002For planned 30 days after the protocol treatment, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;\n9. Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to index procedure;\n10. Lesion location starts ≥1 cm below the common femoral bifurcation and P1 popliteal artery.\n\nExclusion Criteria:\n\n1. Pregnant, lactating, or planning on becoming pregnant or men intending to father children;\n2. Contraindication to stent or DCB or POBA per current information for use (IFU);\n3. Life expectancy of \\\u003C1 year;\n4. Inability to take required antiplatelet\u002Fanticoagulant medications, or known contraindication (including allergic reaction) or sensitivity to contrast media, nickel, titanium or tantalum that cannot be adequately managed with pre- and post-procedure medication;\n5. Intended treatment of outflow disease during the index procedure;\n6. Intended use of laser, atherectomy or cryoplasty during index procedure;\n7. Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target vessel;\n8. History of stroke within 3 months;\n9. History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;\n10. Participation in an investigational drug or another investigational device study until this study's primary endpoint is reached or previous enrollment in this study;\n11. Another medical condition, which, in the opinion of the Investigator, may cause the patient to be noncompliant with the Concern\u002FInformation Need\u002FParticipation Willingness (CIP) or confound data interpretation;\n12. Target vessel and\u002For lesion involves a previously placed stent.","80 Years",{"count":339,"type":22},180,[25],"To compare the efficacy and safety of stent angioplasty with Orchid 035 Drug Coated Dilatation (DCB) and Plain Old Balloon Angioplasty (POBA) for post-dilatation for long (\\>10cm) femoropopliteal chronic total occlusion.",[28],"2026-04-29",{"date":345,"type":41},"2026-05-01",{"date":347,"type":41},"2019-01-01",{"date":349,"type":22},"2026-12-31",{"name":351,"class":47},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University",{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":360,"targetDuration":362,"studyType":112,"phases":4,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":373,"locationsCount":48},"100389155","registry-of-long-term-antithrombotic-therapy-1-100389155","NCT04347200","REGistry of Long-term AnTithrombotic TherApy-1","Registry Dedicated to Assess the Risk of Ischemic and Hemorrhagic Complications of Long-term Antithrombotic Therapy in Patients With Chronic Coronary Syndromes","REGATTA-1","Inclusion Criteria:\n\n* coronary artery disease , confirmed by history of myocardial infarction, or revascularization, or definitive evidence of CAD on imaging\n\nExclusion Criteria:\n\n* Subjects who are unwilling or unable to provide informed consent.\n* Acute coronary syndrome within 12 months before inclusion\n* Severe chronic heart failure (NYHA IV)\n* Stroke within 6 months before inclusion\n* Severe liver or muscle disease\n* Severe kidney disease \u002F renal failure with creatinine \\> 3 mg\u002Fdl\n* Conceivable impossibility to come in touch with the patient or his family at 1-year after the intervention -",{"count":361,"type":22},2000,"5 Years","To assess the rates of ischemic and hemorrhagic complications of long-term antithrombotic therapy in patients with chronic coronary syndromes",[365,28],"Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))",[367],"Coronary Artery Disease, Peripheral Artery Disease","2026-04-27",{"date":345,"type":41},{"date":371,"type":41},"2015-01-15",{"date":349,"type":22},{"name":374,"class":375},"National Medical Research Center for Cardiology, Ministry of Health of Russian Federation","OTHER_GOV",{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":383,"enrollmentInfo":384,"targetDuration":4,"studyType":23,"phases":386,"briefSummary":387,"conditions":388,"keywords":391,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":399,"locationsCount":48},"100301374","red-light-treatment-in-peripheral-artery-disease-100301374","NCT03203239","Red Light Treatment in Peripheral Artery Disease","Vasodilatory Effects of Light on Peripheral Artery Disease","Inclusion Criteria:\n\n* Participants will be subjects between the ages of 18 and 85 who have been diagnosed with peripheral artery disease. Men and women will be recruited for participation. All ethnicities will be included in this study.\n\nDiagnosis of peripheral artery disease is defined as an Ankle Brachial index of \\\u003C0.9 or greater than 1.1 either at rest or during treadmill exercise.\n\nExclusion Criteria:\n\n* Exclusionary criteria include age under 18 years and over 85 years, those who are unable to understand the consent process , those who cannot read or speak English, active pregnancy, hypersensitivity to perflutren contrast agents, pulmonary hypertension, active illicit drug use, untreated blood pressure over 160\u002F95, sickle cell disease, or a history of intracardiac shunt. Additional exclusion criteria neurological diseases such as spinal stenosis, unspecified pain disorders, and any uncontrolled medical conditions.","85 Years",{"count":385,"type":22},40,[25],"Subjects with a known diagnosis of peripheral artery disease as measured by an abnormal ankle brachial index (\\\u003C.9 or \\>1.1) will undergo a single 5 min exposure of 670 nm light, 1 cm above the gastrocnemius muscle. Blood flow will be measured by infusion of ultrasound contrast and subsequent acquisition of ultrasound images. 2 blood samples will be collected for measurement of nitric oxide metabolites.",[28,389,390],"Claudication, Intermittent","Vasodilation",[392,393,394],"red light","vasodilation","nitric oxide",{"date":345,"type":41},{"date":397,"type":41},"2018-01-17",{"date":253,"type":22},{"name":400,"class":47},"University of Alabama at Birmingham",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":18,"minAge":191,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":23,"phases":411,"briefSummary":412,"conditions":413,"keywords":414,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":48},"100430747","exercise-therapy-for-pad-using-mobile-health-100430747","NCT04889105","Exercise Therapy for PAD Using Mobile Health","Enhanced Home-Based Exercise Therapy for Peripheral Arterial Disease Through Mobile Health and Remote Monitoring","Smart MOVE","Inclusion Criteria:\n\n* Age \\>40 years\n* Eligible Veteran status\n* Clinically stable intermittent claudication ( 2 months of Rutherford Class II symptoms, no evidence of chronic limb-threatening ischemia)\n* Established PAD diagnosis (abnormal ankle-brachial index or evidence of PAD on prior certified vascular laboratory or radiology imaging)\n* Access to safe location to perform walking exercises\n\nExclusion Criteria:\n\n* Above or below knee amputation\n\n  * critical limb ischemia (rest pain or tissue loss including ulceration or gangrene)\n  * inability to walk without a walker\n  * wheelchair confinement\n  * non-English speaking\n  * significant visual impairment that interferes with walking activity\n  * hearing impairment that interferes with full study participation\n  * unable or unwilling to return to the medical center at the expected visit frequency or unable or unwilling to use the technology required for the intervention\n* Individuals whose walking is limited by a condition other than PAD\n* Any active cardiac condition including unstable angina\n\n  * unstable atrial or ventricular arrhythmias\n  * high-grade heart block without a pacemaker\n  * active myopericarditis\n  * recent venous thromboembolism\n  * or recent abnormal baseline stress test suggesting ischemia\n  * other high-risk findings (e.g., drop of systolic blood \\> 20 mmHg with exercise)\n* Presence of Class III NYHA heart failure or CCS III angina.\n* Major surgery including lower extremity revascularization or orthopedic surgery during the preceding three months or anticipated in the next nine months\n* Major medical illness including lung disease requiring continuous oxygen (patients wearing nighttime oxygen only may still qualify)\n\n  * neurodegenerative disorders such as Parkinson's Disease that impair walking ability\n  * cancer requiring treatment in the past 2 years (with exception for non-melanoma skin cancer or if they received treatment for early-stage cancer with an excellent overall prognosis)\n* Heart attack, stroke, or coronary artery bypass surgery in the preceding 3 months\n* Mental health illness that may interfere with the ability to consent and\u002For participate in the study, including mini-mental status examination score \\\u003C24\n\n  * dementia\n  * active psychiatric disorder such as schizophrenia or bipolar disorder\n  * history of suicidal or homicidal ideation in the preceding six months\n  * history of suicidal attempts in the preceding 12 months\n  * history of active substance use in the preceding six months that would interfere with study participation (as determined by their primary care or mental health provider)\n* Subjects endorsing SI or HI may be eligible for continued participation with monitoring if approved by their primary mental health provider\n* Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention\n* Currently enrolled in another clinical trial or structured exercise program (i.e., cardiac rehabilitation)\n* Deemed to be poorly suited for the study or the study intervention at the discretion of the PI or study staff",{"count":410,"type":22},75,[25],"Peripheral artery disease (PAD) is a highly prevalent condition affecting up to 10% of Veterans that leads to loss of walking ability and increased risk of amputation. Veterans have limited access to supervised exercise therapy, a facility-based program proven to improve walking ability in PAD, which is poorly attended due to the inconvenience and cost of attending a 12-week program with multiple weekly sessions. This CDA-2 application will investigate the feasibility of home-based exercise therapy (HBET) delivered using mobile health (mHealth) technologies in Veterans with symptomatic PAD. We will partner with the MOVE! program to deliver HBET through group behavioral coaching and a novel wearable activity monitor in a newly proposed program called Smart MOVE!. There is a clear need to provide effective and convenient alternatives to supervised exercise for Veterans with PAD. This study will provide evidence to proceed with Smart MOVE!, a much-needed patient-centered rehabilitation program for Veterans with PAD.",[28],[415,416,417],"Mobile health","Telemedicine","Peripheral artery disease","2026-04-15",{"date":420,"type":41},"2026-04-21",{"date":422,"type":41},"2021-12-01",{"date":424,"type":22},"2026-09-30",{"name":327,"class":328},{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":18,"minAge":191,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":48},"100350609","the-effects-of-diet-and-exercise-interventions-in-peripheral-artery-disease-100350609","NCT03845036","The Effects of Diet and Exercise Interventions in Peripheral Artery Disease","Inclusion Criteria:\n\n1. History of claudication,\n2. Presence of PAD, defined by meeting at least one of the following criteria (ABI at rest \\\u003C 0.90, or \\> 20% decrease in ABI following a heel-rise exercise test in patients with a normal ABI at rest (\\> 0.90), or history of peripheral revascularization.\n\nExclusion Criteria:\n\n1. absence of PAD, defined by meeting all of the following 3 criteria (ABI at rest \\> 0.90), \\\u003C 20% decrease in ABI following a heel-rise exercise test, and no history of peripheral revascularization,\n2. non-compressible vessels (ABI \\> 1.40),\n3. rest pain due to PAD (Fontaine stage III; Rutherford Grade II),\n4. tissue loss due to PAD (Fontaine stage IV; Rutherford Grade III),\n5. use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,\n6. peripheral revascularization within one month prior to investigation,\n7. active cancer,\n8. end stage renal disease defined as stage 5 chronic kidney disease,\n9. medical conditions that are contraindicative for exercise according to the American College of Sports Medicine,\n10. cognitive dysfunction (mini-mental state examination score \\\u003C 24), and\n11. failure to complete the baseline tests within three weeks.",{"count":433,"type":22},150,[25],"This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the DASH dietary program combined with a home-based exercise program, quantified by a step activity monitor, to improve exercise and vascular outcome measures in patients with PAD.",[197,28],"2026-04-13",{"date":439,"type":41},"2026-04-17",{"date":441,"type":41},"2024-09-16",{"date":443,"type":22},"2029-05-31",{"name":206,"class":47},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":23,"phases":455,"briefSummary":456,"conditions":457,"keywords":460,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":48},"100546818","enhancing-exercise-with-light-to-improve-functioning-in-pad-100546818","NCT06399900","ENhancing Exercise With LIGHT to Improve Functioning in PAD","ENhancing Exercise With LIGHT to Improve Functioning in PAD: the ENLIGHTEN PAD Trial","ENLIGHTEN PAD","Inclusion Criteria:\n\nFirst, all participants will be age 50 and older. Second, all participants will have PAD. PAD will be defined as:\n\n1. An ABI \\\u003C= 0.90 at baseline.\n2. Vascular lab evidence of PAD (such as a toe brachial pressure \\\u003C= 0.70 or an ankle brachial index less than or equal to 0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities.\n3. An ABI of \\>0.90 and \\\u003C= 1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test.\n\nExclusion Criteria:\n\n1. Above- or below-knee amputation\n2. Critical limb ischemia defined as an ABI \\\u003C0.40 with symptoms of rest pain\n3. Wheelchair confinement or requiring a walker to ambulate\n4. Walking is limited by a symptom other than PAD\n5. Current foot ulcer on bottom of foot\n6. Failure to successfully complete the study run-in\n7. Planned major surgery, coronary or leg revascularization during the next four months\n8. Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months\n9. Major medical illness including lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. \\[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent, unless the cancer is located in the lower extremities. Participants who require oxygen only at night may still qualify.\\]\n10. Mini-Mental Status Examination (MMSE) score \\\u003C 23\n11. Non-English speaking\n12. Participation in or completion of a clinical trial in the previous three months. \\[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\\]\n13. Visual impairment that limits walking ability.\n14. Six-minute walk distance of \\\u003C400 feet or \\>1700 feet.\n15. Participation in a supervised treadmill exercise program or a cardiac rehabilitation program in previous three months or planning to begin a supervised treadmill exercise program or a cardiac rehabilitation program in the next five months.\n16. Unwilling to avoid red light therapy outside of study participation.\n17. Baseline blood pressure \\\u003C100\u002F45.\n18. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.",{"count":454,"type":22},32,[25],"The ENLIGHTEN PAD Trial will collect preliminary data to test whether daily 660 nm light treatment of the lower extremities immediately before home-based walking exercise sessions improves six-minute walk distance at 4-month follow-up, compared to sham light, in people with lower extremity peripheral artery disease (PAD).",[28,34,458,459],"Aging","Walking, Difficulty",[461,147,462],"light therapy","exercise","2026-04-11",{"date":418,"type":41},{"date":466,"type":41},"2024-08-12",{"date":468,"type":22},"2027-01-31",{"name":232,"class":47},{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":23,"phases":480,"briefSummary":481,"conditions":482,"keywords":483,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":491},"100487211","beetroot-juice-to-reverse-functional-impairment-in-pad-100487211","NCT05624125","BEETroot Juice to Reverse Functional Impairment in PAD","BEETroot Juice to Reverse Functional Impairment in PAD: The BEET PAD Trial","BEET PAD","Inclusion Criteria:\n\n1. Age 50 and older\n2. Presence of peripheral artery disease, defined as:\n\n   1. An ankle brachial index (ABI) \\\u003C= 0.90 at baseline\n   2. Vascular lab evidence of PAD (such as a toe brachial pressure \\\u003C= 0.70 or an ankle brachial index \\\u003C=0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities.\n   3. An ABI of \\>0.90 and \\\u003C=1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test.\n\nExclusion Criteria:\n\n1. Above- or below-knee amputation\n2. Critical limb ischemia defined as an ABI \\\u003C0.40 with symptoms of rest pain\n3. Wheelchair confinement or requiring a walker to ambulate\n4. Walking is limited by a symptom other than PAD\n5. Current foot ulcer on bottom of foot\n6. Failure to successfully complete the study run-in\n7. Planned major surgery, coronary or leg revascularization during the next five months\n8. Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months\n9. Major medical illness including lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. \\[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who require oxygen only at night may still qualify.\\]\n10. Mini-Mental Status Examination (MMSE) score \\\u003C 23\n11. Allergy to beetroot juice\n12. Currently consuming beetroot juice, oral nitrate or nitrite, or a beetroot supplement and\u002For unwilling to avoid beetroot juice during the study. Participants will be asked to discontinue these items for 30 days before baseline testing and throughout the clinical trial. If the potential participant is unwilling to refrain from taking these items, they will not be eligible for the clinical trial.\n13. Currently consuming one cup or more of beets daily. Participants will be asked to discontinue beet ingestion of one cup or more of beets for 30 days before baseline testing and throughout the clinical trial. If the potential participant is unwilling to refrain from daily beet consumption of one cup or more for 30 days before the trial and during the trial, they will not be eligible for the clinical trial.\n14. Non-English speaking\n15. Participation in or completion of a clinical trial in the previous three months. \\[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\\]\n16. Visual impairment that limits walking ability.\n17. Six-minute walk distance of \\\u003C500 feet or \\>1600 feet. Investigator discretion will be used to decide whether participants who walk greater than 1600 feet are eligible.\n18. Baseline blood pressure \\\u003C100\u002F45.\n19. Participation in a supervised treadmill exercise program in previous three months.\n20. Using an antibacterial mouthwash (such as Cepacol) or a mouthwash containing chlorhexidine and unwilling to discontinue.\n21. An eGFR value \\\u003C30 or potassium \\>5.0.\n22. History of kidney stones that requires minimized intake of oxalate. Potential participants who need to minimize oxalate intake will be excluded from the trial.\n23. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.",{"count":479,"type":22},210,[25],"The BEET PAD Trial is a multi-centered double-blind randomized clinical trial designed to determine whether beetroot juice, compared to placebo, improves six-minute walk distance at four month follow-up in people with lower extremity peripheral artery disease (PAD). Investigators hypothesize that by simultaneously increasing lower extremity perfusion, gastrocnemius muscle mitochondrial activity, and myofiber health and regeneration, beetroot juice will significantly improve walking performance in people with PAD. The primary aim is to determine whether beetroot juice significantly improves six-minute walk distance at 4-month follow-up in people with PAD, compared to placebo. Preliminary evidence suggests that beetroot juice has both acute and chronic effects on walking performance in PAD. The primary outcome will measure the combined acute and chronic effect of beetroot juice (i.e. the maximal effect) on change in 6-minute walk at 4-month follow-up. In secondary aims, investigators will distinguish between acute and chronic effects of beetroot juice on six-minute walk and delineate biologic pathways by which beetroot juice improves walking performance in PAD, by measuring change in gastrocnemius muscle perfusion (MRI arterial spin labeling) and gastrocnemius muscle health. The trial will assess the durability of beetroot juice effects on six-minute walk. Nitrate in beetroot juice is metabolized to nitrite and subsequently to NO, attaining peak nitrite levels 2.5 hours after ingestion. The trial will determine whether a higher peak or a greater increase in plasma nitrite at 2.5 hours after beetroot juice consumption at baseline has a greater effect on six-minute walk at 4-month follow-up, compared to a lower peak or a smaller increase, respectively.",[28],[484],"beetroot juice, mobility, intermittent claudication, peripheral artery disease",{"date":418,"type":41},{"date":487,"type":41},"2023-01-25",{"date":489,"type":22},"2028-10-01",{"name":232,"class":47},4,{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":18,"minAge":191,"maxAge":500,"enrollmentInfo":501,"targetDuration":4,"studyType":23,"phases":503,"briefSummary":504,"conditions":505,"keywords":508,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":520},"100362134","optimizing-gait-rehabilitation-for-veterans-with-non-traumatic-lower-limb-amputation-100362134","NCT03995238","Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation","Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation","GEM","Inclusion Criteria:\n\n* Unilateral, non-traumatic, transtibial amputation\n* Diabetes mellitus and\u002For peripheral artery disease\n* Able to ambulate in the community without assistive device\n* Step length asymmetry during walking (\\>1.0 asymmetry index.)\n* 6 months since amputation\n\nExclusion Criteria:\n\n* Unstable heart condition\n* Including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis\n* Acute systemic infection\n* Active cancer treatment\n* Traumatic or cancer related amputation etiology","89 Years",{"count":502,"type":22},54,[25],"The population of older Veterans with non-traumatic lower limb amputation is growing. Following lower limb amputation, asymmetrical movements persist during walking and likely contribute to disabling sequelae including secondary pain conditions, poor gait efficiency, impaired physical function, and compromised skin integrity of the residual limb. This study seeks to address chronic gait asymmetry by evaluating the efficacy of two error-manipulation gait training programs to improve gait symmetry for Veterans with non-traumatic lower limb amputation. Additional this study will evaluate the potential of error-manipulation training programs to improve secondary measures of disability and residual limb skin health. Ultimately, this study aims to improve conventional prosthetic rehabilitation for Veterans with non-traumatic amputation through gait training programs based in motor learning principles, resulting in improved gait symmetry and lower incidence of long-term disability after non-traumatic lower limb amputation.",[506,28,507],"Transtibial Amputation","Diabetes Mellitus",[509,510,511,512,28],"Amputation","Rehabilitation","Gait Training","Diabetes","2026-04-06",{"date":437,"type":41},{"date":516,"type":41},"2019-10-09",{"date":518,"type":22},"2026-10-31",{"name":327,"class":328},2,{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":529,"targetDuration":531,"studyType":112,"phases":4,"briefSummary":532,"conditions":533,"keywords":536,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":549},"100486901","durg-coated-balloon-angioplasty-in-infrapopliteal-lesions-100486901","NCT05620095","Durg Coated Balloon Angioplasty in Infrapopliteal Lesions","Multicenter Registry for pAclitaxel- Coated Balloon angioplasTy in Infrapopliteal Arterial Lesions (the ACT Study)","Act","Inclusion Criteria:\n\n1. Rutherford grade 4-6.\n2. Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.\n3. Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the infrapopliteal arteries \\>20 mm. Lesions should not extend beyond the ankle joint.\n4. Successful wire crossing of the lesion. After the pre-dilation of the ordinary balloon, the angiography showed that there was continuous blood flow.\n5. At least one of the infrapopliteal arteries received a drug-coated balloon.\n6. For patients with aortoiliac artery disease and femoral-popliteal artery disease, after intravascular reconstruction, blood flow can be recanalized, and there is no residual stenosis of more than 50%.\n7. In patients with lower extremity arterial thrombosis, after mechanical thrombectomy, percutaneous catheter thrombolysis, and thrombus removal, patients receiving blew the knee arterial drug balloon intervention.\n8. Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time.\n9. Life expectancy\\> 24 months.\n\nExclusion Criteria:\n\n1. Blood flow was not successfully reestablished.\n2. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.\n3. Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.\n4. Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months.\n5. Pregnant and lactating women.\n6. Patients with Berg's disease.\n7. Patients requiring major amputation based on preoperative evaluation of limb infection or severe ischemia",{"count":530,"type":22},1000,"1 Year","This study is a multicenter observational study designed to evaluate the the effectiveness and safety of drug-coated balloon (DCB) angioplasty for below the knee arterial lesions in patients critical with Limb Threatening Ischemia (CLTI).",[534,28,535],"Arteriosclerosis","Chronic Limb Threatening Ischemia",[537,538,539],"Drug-coated Balloon","Angioplasty","Below the knee","2026-03-20",{"date":542,"type":41},"2026-03-25",{"date":544,"type":41},"2020-12-01",{"date":546,"type":22},"2026-11-01",{"name":548,"class":47},"Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology",10,{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":56,"sex":18,"minAge":310,"maxAge":557,"enrollmentInfo":558,"targetDuration":4,"studyType":23,"phases":559,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":292,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":567,"leadSponsor":569,"locationsCount":4},"100544474","early-phase-1-vitamin-b6-on-exercise-pressor-reflex-on-leg-ischemia-reperfusion-100544474","NCT06369350","Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion","Effects of Vitamin B6 on the Exercise Pressor Reflex in Lower Limb Ischemia-Reperfusion","Inclusion Criteria:\n\n* Are males and females at least 21- 70 years of age (inclusive)\n* Capable of giving informed consent\n* Are of any race or ethnicity\n* Can communicate in English\n* Females may be on oral contraceptives but will be excluded if they are pregnant or lactating\n* Healthy Status as defined by the absence of evidence of any active or chronic disease as determined by the following:\n* a detailed medical history\n* complete physical examination (including vital signs)\n* a blood pressure that is within a safe range (\\\u003C150\u002F100mmHg)\n\nExclusion Criteria:\n\n* \\\u003C 21 years of age or \\> 70 years of age\n* Pregnant or nursing woman\n* Prisoners or institutionalized individuals unable to consent\n* Decisional impairment\n* Not able to communicate in English.\n* Current smoker\n* Have any clinically relevant history or the presence of metabolic (e.g., diabetes), respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, or other disease or diseases that, in the opinion of the research team, exclude the subject from participation.\n* Presenting with a resting blood pressure of 150\u002F100 or higher\n* Taking any medications that affect vascular control or autonomic function (e.g. beta blockers, ACE inhibitors, calcium channel blockers, etc.)\n* Taking a multivitamin with B6, a B-complex vitamin, or vitamin B-6 at baseline, with a history of Parkinson's disease, and taking levodopa\n* Known allergy or hypersensitivity to Vitamin B6\n* Opioid Use Disorder or on opioid therapy\n* Subject has a recent drug or alcohol abuse history (less than 6 months) or is currently using or abusing excessive alcohol or drugs. Excessive alcohol will be defined as greater than 14 drinks per week. Use of recreational drugs in the past 6 months is also an exclusion.","70 Years",{"count":288,"type":22},[62],"In this study, we are trying to see if vitamin B6 can minimize the amplified blood pressure response to exercise following ischemia-reperfusion injury. We are interested in a protein called P2X3, of which function can be blocked by vitamin B6, in the neurons of our nervous system. It is very important for blood pressure regulation. We would like to see if the P2X3 plays a role in patients' rising blood pressure during exercise. The results of the proposed studies will provide a base for those two potential economic and non-invasive inventions to improve the overall health and well-being of PAD patients.",[562,28],"Ischemia Reperfusion Injury","2026-03-16",{"date":565,"type":41},"2026-03-17",{"date":179,"type":22},{"date":568,"type":22},"2028-09",{"name":570,"class":47},"Milton S. Hershey Medical Center",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":23,"phases":580,"briefSummary":581,"conditions":582,"keywords":583,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":594,"locationsCount":48},"100516387","oxygen-guided-supervised-exercise-therapy-100516387","NCT06003855","Oxygen-guided Supervised Exercise Therapy","Oxygen-guided Supervised Exercise Therapy in Peripheral Artery Disease","MOMET","Inclusion Criteria:\n\nAt entry into the study, all subjects must:\n\n* Be able to give written, informed consent\n* Have documented lower extremity arterial occlusive disease based on ankle\u002Fbrachial index measurements and\u002For arterial imaging\n* Demonstrate positive history of chronic claudication\n* Have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks\n\nExclusion Criteria:\n\nAny potential subjects will be excluded if they have:\n\n* Rest pain or tissue loss due to PAD (Fontaine stage III and IV)\n* Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma\n* Walking capacity limited by conditions other than claudication including leg (joint\u002Fmusculoskeletal, neurologic) and systemic (heart, lung disease) pathology",{"count":21,"type":22},[25],"Peripheral artery disease (PAD) is a cardiovascular disease manifesting from systemic atherosclerosis, which blocks the leg arteries and results in insufficient blood flow to the lower extremities. Limb ischemia from PAD is the most common disorder treated within the vascular surgery service at the Omaha Veterans' Affairs Medical Center. PAD also accounts for one-third of the operations performed in the VA Medical Centers nationwide. This project aims to establish the feasibility and acceptability of a muscle oxygen-guided supervised exercise program for patients with PAD. The investigators will determine the potential benefits of using this intervention over standard supervised exercise therapy. This modified intervention may enable patients to increase overall physical activity without the negative impacts on muscle structure and function. Increasing physical activity will decrease cardiovascular morbidity and mortality. If proven beneficial, the findings will lead to an improved exercise program that directly benefits veterans nationwide.",[28],[584,585,586,587],"peripheral arterial disease","atherosclerosis","arterial occlusive disease","gait","2026-01-09",{"date":590,"type":41},"2026-01-13",{"date":592,"type":41},"2023-10-01",{"date":99,"type":22},{"name":327,"class":328},{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":604,"briefSummary":605,"conditions":606,"keywords":607,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":617,"locationsCount":48},"100474989","leg-heat-therapy-in-peripheral-artery-disease-100474989","NCT05465070","Leg Heat Therapy in Peripheral Artery Disease","Leg Heat Therapy to Improve Functional Performance in Peripheral Artery Disease","Inclusion Criteria:\n\n* Men and women older than 50 years\n* Resting ankle-brachial index (ABI) of 0.9 or less in at least one leg. Individuals with a resting ABI between 0.91 and 1.00 at baseline will be eligible if their ABI drops by 20% or greater following a heel-rise test.\n\nExclusion Criteria:\n\n* Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss)\n* Prior foot or leg amputation\n* Exercise tolerance limited by factors other than leg pain (e.g. angina, arthritis, severe lung disease, etc).\n* Recent (\\\u003C3 months) lower-extremity revascularization or orthopedic surgery\n* Use of walking aid other than a cane\n* Active cancer\n* Chronic kidney disease (eGFR \\\u003C30 by MDRD or Mayo or Cockcroft-Gault formula)\n* Class 2 or 3 obesity (BMI ≥ 35 kg\u002Fm2)\n* Unable to fit into water-circulating trousers\n* A Mini-Mental Status Examination score \\\u003C23\n* Impaired thermal sensation in the leg\n\nAs this study involves MR imaging, patients that have contraindications to MRI will be included in the study but will not be allowed to participate in the MRI experiment. Information about biomedical devices that may pose a risk to patients undergoing MRI is available on the Internet at www.MRIsafety.com. These exclusions include: cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, insulin or infusion pump, implanted drug infusion device, bone growth\u002Ffusion stimulator, cochlear, otologic, or ear implant and history of claustrophobia or who are unable to lie flat or who do not fit inside the bore of the scanner.",{"count":603,"type":22},106,[25],"The goal of this randomized, double-blind, sham-controlled clinical trial is to evaluate the benefits of home-based, leg heat therapy (HT) on lower-extremity functioning and quality of life in patients who suffer from lower-extremity peripheral artery disease (PAD). We will randomize 106 patients to one of two groups that either receive leg HT or a sham intervention. The primary study outcome is the change in 6-minute walk distance between baseline and the 12-week follow up. Secondary outcomes include changes in the short physical performance battery score, handgrip strength, quality of life (measured by the Walking Impairment Questionnaire and Short-Form (SF)-36 Questionnaire), calf muscle strength (measured using a calf ergometer), size (measured by magnetic resonance imaging) and bioenergetics (assessed using phosphorus-31 magnetic resonance spectroscopy), and physical activity (measured by accelerometer).",[28],[608,147,609,610],"heat therapy","walking performance","muscle strength","2026-01-04",{"date":613,"type":41},"2026-01-06",{"date":615,"type":41},"2022-11-07",{"date":349,"type":22},{"name":618,"class":47},"Indiana University",{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":628,"conditions":629,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":48},"100487581","vascular-lab-resource-vlr-biorepository-100487581","NCT05628948","Vascular Lab Resource (VLR) Biorepository","Vascular Lab Resource (VLR) Biorepository Study","Inclusion Criteria:\n\n1. 18 years or older\n2. Subjects capable of providing informed consent document\n3. Subjects with diagnosed with or at risk for cardiovascular and metabolic diseases\n\nExclusion Criteria:\n\n1. Known life expectancy of ≤ 6 months at the time of enrollment\n2. Known current pregnancy\n3. Severe Anemia (last documented hemoglobin \\\u003C 7.0 g\u002FdL)",{"count":627,"type":22},500,"This is a study of biomarkers obtained from prospectively collected subject samples and their correlation with cardiovascular and metabolic diseases. The purpose of this initiative is to develop an enduring tool to allow for collaborative research between clinicians at Cleveland Clinic Main Campus and basic scientists at the Lerner Research Institute. This collaboration will allow resources to be available to clinical and basic researchers alike. This tool will enable research of vascular disease in the Vascular Lab and will leverage this valuable asset to the fullest extent to allow for interdepartmental collaboration.",[630,631,28,632,633,634,635,636,637,638,639,640,641,642,643,644],"Cardiovascular Diseases","Metabolic Disease","Carotid Disease","Aneurysmal Disease","Venous Disease","Thrombosis","Lymphedema","Lipedema","Non-Atherosclerotic Chronic Arterial Occlusive Disease","Vasculitis","Fibromuscular Dysplasia","Arterial Dissection","May-Thurner Syndrome","Thoracic Outlet Syndrome","Vasospasm","2025-12-15",{"date":647,"type":41},"2025-12-19",{"date":649,"type":41},"2019-11-14",{"date":651,"type":22},"2031-06-30",{"name":653,"class":47},"The Cleveland Clinic"]