[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peripheral-vascular-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peripheral-vascular-diseases":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,47,74,100,124,159,187,210,229,260,285,302,334,352,381,404],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100432839","examining-the-impact-of-exercise-training-on-vascular-dysfunction-in-individuals-with-mental-health-disorders---study-1-100432839",false,"NCT04916327","Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1","Inclusion Criteria:\n\n* apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease\n* for PTSD group, a score of ≥ 33 on PCL-5 checklist\n* for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and \\\u003C 33 on the PCL-5 checklist\n* for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and \\\u003C 33 on the PCL-5 checklist\n\nExclusion Criteria:\n\n* taking medications that could influence cardiovascular function\n* current smokers who have recently quit smoking\n* illicit drug use or excessive alcohol consumption\n* pregnant women\n* significant calorie restriction or vitamin\u002Fmineral deficiencies\n* limited English proficiency",true,"ALL","18 Years","35 Years",{"count":20,"type":21},720,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and\u002For generalized anxiety disorder (GAD)).",[27],"Peripheral Vascular Diseases",[29,30,31,32,33],"cardiovascular disease","vascular function","PTSD","GAD","Oxidant","RECRUITING","2026-06-29",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":38},"2021-08-23",{"date":42,"type":21},"2026-08",{"name":44,"class":45},"Virginia Commonwealth University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":15,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":46},"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","50 Years","75 Years",{"count":57,"type":21},20,[59],"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.",[62,27,63,64],"Peripheral Artery Disease","Peripheral Arterial Disease","Peripheral Arterial Occlusive Disease","2026-06-19",{"date":67,"type":38},"2026-06-24",{"date":69,"type":38},"2024-11-14",{"date":71,"type":21},"2026-12",{"name":73,"class":45},"University of Nebraska",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":46},"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":82,"type":21},400,[24],"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.",[62,27,86],"Dyslipidemias",[88,62,89,90],"Dyslipidemia","Peripheral Vascular Disease","Computerized Decision Support","2026-06-16",{"date":93,"type":38},"2026-06-17",{"date":95,"type":38},"2023-03-01",{"date":97,"type":21},"2026-12-30",{"name":99,"class":45},"Brigham and Women's Hospital",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":110,"studyType":111,"phases":4,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":123},"100414311","drug-eluting-registry-real-world-treatment-of-lesions-in-the-peripheral-vasculature-100414311","NCT04674969","Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature","Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE)","ELEGANCE","Inclusion Criteria:\n\n* Patients 18 years and older\n* Written informed consent (patient data release-form)\n* Use of any commercially available Boston Scientific drug-eluting device marketed for treatment of lesions in the peripheral vasculature and specified in the Registry Enrollment Guide\n\nExclusion Criteria:\n\n* Life expectancy of \\\u003C1 year",{"count":109,"type":21},5000,"5 Years","OBSERVATIONAL","The ELEGANCE Registry's objective is to collect Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trials, health economics data, and to support the safe use of commercially available Boston Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.",[27],"2026-06-13",{"date":91,"type":38},{"date":117,"type":38},"2021-03-29",{"date":119,"type":21},"2028-01",{"name":121,"class":122},"Boston Scientific Corporation","INDUSTRY",79,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":46},"100640148","peripheral-vascular-disease-as-a-clinical-trigger-for-opportunistic-lung-cancer-screening-referral-an-implementation-study-100640148","NCT07598279","Peripheral Vascular Disease as a Clinical Trigger for Opportunistic Lung Cancer Screening Referral: An Implementation Study","Peripheral Vascular Disease as a Clinical Trigger for Opportunistic Lung Cancer Screening Referral: A Tertiary Care Implementation Study","PVD-Lungs","Inclusion Criteria:\n\n* All patients known\u002Fsuspected to have peripheral vascular disease attending specified clinics in the tertiary care hospital\n\nExclusion Criteria:\n\n* Prior diagnosis of lung cancer established\u002Fon work-up\n* Patients with no smoking history\n* Patients not eligible for low-dose CT scan","40 Years","80 Years",{"count":135,"type":21},355,[24],"The study aims to determine whether patients with peripheral vascular disease who attend the vascular clinics are eligible for lung cancer screening. This is because long-term cigarette smoking exposure is associated with peripheral vascular disease, and smoking is again the main risk factor for lung cancer.\n\nThese clinical encounters provide a potential opportunity to identify individuals who may qualify for lung cancer screening but are not routinely assessed for screening eligibility. Integrating systematic screening eligibility assessment within vascular clinics could therefore represent an effective strategy for identifying high-risk individuals and improving referral for lung cancer screening.\n\nAdditionally, peripheral arterial disease is commonly diagnosed using the ankle-brachial index (ABI), a non-invasive measure that compares systolic blood pressure between the ankle and brachial arteries. An ABI value below 0.90 is widely recognised as diagnostic of peripheral arterial disease and reflects the presence of systemic atherosclerosis.\n\nABI has been increasingly recognized as a marker of cumulative exposure to cardiovascular risk factors, particularly long-term tobacco smoking. Tobacco smoking contributes to endothelial dysfunction, chronic inflammation, and atherosclerotic plaque formation, mechanisms that are also implicated in lung carcinogenesis.\n\nBecause both lung cancer and peripheral vascular disease share major risk factors, ABI may serve as a clinical proxy indicator of cumulative smoking-related vascular damage. Individuals with lower ABI values may therefore represent a subgroup with higher cumulative tobacco exposure and potentially elevated lung cancer risk.\n\nEvaluating the association between ABI severity categories and lung cancer diagnosis may provide insights into whether vascular disease severity could help identify individuals who may benefit from targeted screening interventions. If an association is observed, ABI could potentially be used as a simple, routinely measured clinical indicator to prompt lung cancer screening assessment in vascular care settings.\n\nTherefore, this study will determine the proportion of the vascular disease patients who fall under the high-risk group for lung cancer screening and refer them to low-dose CT scan and follow-up them for the results and the adherence.",[139,27,140,141],"Lung Cancer","Ankle Brachial Index","Low Dose Computed Tomography",[143,144,145,146,147,148],"lung cancer","peripheral vascular disease","ankle brachial index","low dose computed tomography","lung cancer screening","opportunistic screening","NOT_YET_RECRUITING","2026-05-18",{"date":152,"type":38},"2026-05-20",{"date":154,"type":21},"2026-06-01",{"date":156,"type":21},"2027-03",{"name":158,"class":45},"International Agency for Research on Cancer",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":171,"conditions":172,"keywords":176,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":46},"100546811","phase-2-fisetin-to-reduce-senescence-and-mobility-impairment-in-pad-100546811","NCT06399809","Fisetin to Reduce Senescence and Mobility Impairment in PAD","Fisetin to Reduce Senescence and Mobility Impairment in Peripheral Artery Disease: the FIRST Pilot Randomized Trial","FIRST","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 ankle brachial index (ABI) less than or equal to 0.90 at baseline.\n2. Vascular lab evidence of PAD (such as a toe brachial pressure less than or equal to 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 greater than 0.90 and less than or equal to 1.00 who experience 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 defined as an ABI less than 0.40 with signs or symptoms of 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 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 less than 23\n11. Allergy to fisetin\n12. Currently taking fisetin or has taken fisetin in previous three months\n13. Non-English speaking\n14. Current participation in or completion of a clinical trial intervention 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 clinical trial (other than stem cell or gene therapy), participants will be eligible after the final study intervention 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 less than 500 feet or greater than1600 feet.\n17. Participation in a supervised treadmill exercise program in previous three months.\n18. Participants may be excluded if they are unwilling to undergo a fat biopsy. However, if investigators find recruitment significantly slows due to this exclusion, participants may still be able to participate in the trial if they refuse the fat biopsy.\n19. Women who are not menopausal will be excluded. Menopause is defined as absence of a menstrual period in the past 12 months.\n20. People with a bilirubin above 2.2 mg\u002Fdl, with serum aspartate transaminase (AST) or alanine aminotransferase (ALT) more than four times the upper limit of normal.\n21. Hemoglobin less than 7.0 g\u002Fdl, white blood count less than 2,000\u002Fmm3, white blood count greater than 20,000\u002Fmm3, platelet count less than 40,000\u002FuL.\n22. Estimated glomerular filtration rate (eGFR) less than 25 ml\u002Fmin\u002F1.73 m2\n23. HemoglobinA1C great than 10 as a marker of poor diabetes control.\n24. People who are Human Immunodeficiency Virus positive (HIV+) and people with active hepatitis B or active hepatitis C infections who do not have a low viral load.\n25. People taking warfarin and other sensitive substrates of CYP2C9, CYP2C19, or CYP1A2 that have a narrow therapeutic window will be excluded, unless the drug can be held for at least two days prior to the first day of each study drug administration and can continue to be held for ten hours after the second dose of study drug administration for each of the two days of study drug dosing.\n26. Body mass index (BMI) great than 43.\n27. 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. In some instances, patients whose medications or laboratory data meet exclusion criteria may participate at the Principal Investigator's discretion.",{"count":168,"type":21},34,[170],"PHASE2","The investigators propose a pilot randomized trial to gather preliminary data to test the hypothesis that Fisetin will reduce abundance of senescent cells in blood, skeletal muscle, and both subcutaneous and inter muscular adipose tissue and improve 6-minute walk distance in 34 people with peripheral artery disease (PAD). the investigators will determine whether greater declines in abundance of cells with senescent markers are associated with greater improvement in 6-minute walk distance in people with peripheral artery disease. In exploratory analyses, the investigators will assess whether Fisetin reduces interleukin-6 (IL-6) and novel senescent markers in adipose tissue, muscle, and\u002For blood.",[63,173,27,174,175],"Aging","Walking, Difficulty","Claudication",[177],"Fisetin","2026-04-11",{"date":180,"type":38},"2026-04-15",{"date":182,"type":38},"2024-09-30",{"date":184,"type":21},"2027-06",{"name":186,"class":45},"Northwestern University",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":198,"conditions":199,"keywords":200,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},"100518555","phase-3-smart-exercise-for-pad-100518555","NCT06032065","SMART Exercise for PAD","Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for Peripheral Artery Disease: The SMART PAD Trial","Inclusion Criteria:\n\nFirst, all participants will be age 50 and older. Second, all participants will have PAD. PAD will be defined as either:\n\n1. An ABI \\\u003C= 0.90 at baseline.\n2. Vascular lab evidence of PAD (such as a toe brachial pressure less than or equal to 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 \\\u003C1.00 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. Limb-threatening 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 condition other than PAD\n5. Current foot ulcer on bottom of foot\n6. Unwilling to drink beetroot juice\n7. Unwilling to accept randomization into either group (home based exercise or supervised exercise)\n8. Planning to engage in new walking exercise outside of the study or unwilling to refrain from new walking exercise activity during the trial.\n9. Already exercising at a level consistent with exercise intervention.\n10. End-stage kidney disease (ESKD) associated with the need for dialysis.\n11. Planned major surgery, coronary or leg revascularization during the next six months\n12. Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months\n13. 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.\\]\n14. Mini-Mental Status Examination (MMSE) score \\\u003C 23 or dementia. However, if the MMSE is \\\u003C 23 and the Principal Investigator evaluation determines that the lower score is related to language barriers or education level, the Principal Investigator has discretion to allow a participant with MMSE \\\u003C 23 to participate, as appropriate.\n15. Allergy to beetroot juice\n16. Currently consuming beetroot juice or oral nitrate or nitrite, or a beetroot supplement, and\u002For unwilling to avoid these during study participation. Participants currently consuming one cup of beets daily will be asked to discontinue beet ingestion 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, they will not be eligible for the clinical trial.\n17. Unstable angina\n18. Abnormal baseline stress test without subsequent clearance for exercise by physician\n19. Non-English speaking. The SMART PAD interventions are delivered by interventionists who do not speak non-English languages. The integrity of the clinical trial requires clear and effective communication for data collection and intervention delivery. The trial does not have staff members who are fluent in non-English languages, nor does it have the ability to translate all study materials into other languages.\n20. 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.\\] Participants in a study that involved up to three single doses of nitrate-rich beetroot juice administered on separate days may participate if a month has passed since their last dose of nitrate-rich beetroot juice.\n21. Visual impairment that limits walking ability.\n22. Baseline blood pressure \\\u003C100\u002F45.\n23. Participation in a supervised treadmill exercise program or cardiac rehabilitation program in previous three months.\n24. Using a mouthwash containing chlorhexidine or cetylpyridinium chloride or a mouthwash determined to be bactericidal and unwilling to discontinue.\n25. An eGFR value \\\u003C30 or potassium \\>5.0.\n26. History of kidney stones that requires minimized intake of oxalate. Potential participants who need to minimize oxalate intake will be excluded from the trial.\n27. 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":195,"type":21},210,[197],"PHASE3","Supervised exercise therapy (SET), consisting of treadmill exercise conducted three times weekly at a center while supervised by healthcare personnel, is first line therapy for people disabled by lower extremity peripheral artery disease (PAD). However, travelling three times\u002Fweek to a center for SET is burdensome. Compared to SET, home-based exercise is more accessible and less burdensome. Yet, evidence-based guidelines recommend SET over home-based exercise for PAD. Walking exercise is first line therapy to improve walking distance for PAD, but it does not eliminate ischemic leg symptoms in most people with PAD. The investigators' work and that of others showed that nitrate-rich beetroot juice, which increases plasma nitrite, limb perfusion, and skeletal muscle function, significantly improved exercise tolerance and reduced non-response to exercise in people with and without PAD. The investigators will use a 2 x 2 factorial design to address two major barriers to achieving benefits from exercise therapy for PAD: First, guideline recommendations for supervised exercise therapy (SET) as first line therapy for PAD. Second, the inability of exercise therapy to eliminate PAD-related disability in most people with PAD. Participants will be randomized to one of four groups for 12 weeks: Supervised treadmill exercise + nitrate rich beetroot juice; supervised treadmill exercise + placebo, home-based walking exercise + nitrate rich beetroot juice, home-based walking exercise + placebo.",[63,173,27,174],[201,202],"behavior change","patient reported outcome measure",{"date":180,"type":38},{"date":205,"type":38},"2023-09-08",{"date":207,"type":21},"2029-03-31",{"name":186,"class":45},3,{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":214,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":215,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":218,"conditions":219,"keywords":220,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":46},"100432840","examining-the-impact-of-exercise-training-on-vascular-dysfunction-in-individuals-with-mental-health-disorders---study-3-100432840","NCT04916340","Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 3",{"count":216,"type":21},240,[24],"The purpose of this research study is to examine the effect of various forms of exercise training on blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and\u002For generalized anxiety disorder (GAD)).",[27],[29,30,31,32,33],"2026-03-30",{"date":223,"type":38},"2026-04-01",{"date":225,"type":38},"2022-01-24",{"date":227,"type":21},"2026-12-28",{"name":44,"class":45},{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":243,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":259},"100566577","phase-3-a-contrast-medium-sparing-strategy-using-automated-co2-injection-during-pvi-for-prevention-of-major-adverse-kidney-events-make-100566577","NCT06656988","A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)","A Contrast Medium Sparing Strategy Using Automated Carbon Dioxide Injection During PERIpheral Vascular Interventions for PREVENTion of Major Adverse Kidney Events (MAKE): the PeriPREVENT Randomized Controlled Trial","PeriPREVENT","Inclusion Criteria:\n\n1. Symptomatic peripheral arterial disease presenting with either acute symptoms (Rutherford clinical categories I-IIb) or chronic symptoms (Fontaine stages IIb-IV or Rutherford clinical categories 2-6)\n2. Planned peripheral vascular intervention of infrainguinal arteries due to femoropopliteal and\u002For infrapopliteal lesions\n3. Increased risk of CA-AKI identified by a baseline risk score of ≥ 5 points based on a published dedicated PVI risk score and a pre-angiographic estimated glomerular filtration rate (eGFR) \\< 60 ml\u002Fmin\u002F1.73 m²\n4. Both angiographic strategies seem feasible at the investigator's discretion\n5. Age 18 years or older\n6. Written informed consent\n\nExclusion Criteria:\n\n1. Very agitated patients\n2. Patients with planned full anaesthesia during procedure\n3. Patients with a life-expectancy less than one year\n4. Patients confined to bed that are completely non-ambulatory\n5. Known acute renal failure or known unstable renal function as evidenced by a recent increase in serum creatinine (SCr) of \\> 0.5 mg\u002Fdl or \\> 25% within 7 days\n6. Iodinated contrast medium exposure within 7 days prior to procedure with change in SCr ≥ 0.1 mg\u002Fdl on two SCr measures ≥ 24 h apart\n7. Advanced chronic kidney disease (CKD) with an eGFR \\< 30 ml\u002Fmin\u002F1.73m² and\u002For dialysis\n8. Current use of nephrotoxic agents (aminoglycoside antibiotics, sulfonamides, amphotericin B, or pentamidine), or an active chemotherapy agent\n9. Acute or chronic pulmonary disease requiring oxygen therapy\n10. Patients with known patent foramen ovale or atrial septal defect\n11. Patients with planned nitrous oxide anaesthesia during intervention\n12. Patients with manifest hyperthyroidism or manifest thyrotoxicosis\n13. Known allergies or hypersensitivity to iodinated contrast media that cannot be adequately pre-treated prior to index procedure\n14. Patients with decompensated heart failure\n15. Patients with manifest tetany\n16. Planned further procedure with a need for \\> 10 ml of iodinated contrast medium (CM) in any location (e.g., CT scan, coronary angiography) within a period of 90 days\n17. Any surgical procedure (except minor amputations) or intervention performed within 30 days prior to or planned within 90 days post index procedure\n18. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) until day 30 after PVI.\n19. Participation in other interventional trials. Exceptions are described in the trial protocol.\n20. Suspected lack of compliance\n21. Pregnant or nursing women",{"count":238,"type":21},1960,[197],"The primary objective of the trial is to evaluate if an iodinated contrast medium sparing strategy using automated Carbon Dioxide (CO2) Injection prevents Major Adverse Kidney Events up to 90 days (MAKE90) in patients at moderately elevated risk for contrast-associated acute kidney injury (CA-AKI) undergoing infrainguinal peripheral vascular interventions (PVI).",[27,242],"Kidney Diseases",[244,245,246,247,248,249],"carbon dioxide","contrast medium","iodinated contrast medium","CA-AKI","angiography","angioplasty","2026-03-18",{"date":252,"type":38},"2026-03-23",{"date":254,"type":38},"2025-04-14",{"date":256,"type":21},"2029-02",{"name":258,"class":45},"University of Leipzig",11,{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":266,"targetDuration":268,"studyType":111,"phases":4,"briefSummary":269,"conditions":270,"keywords":271,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":46},"100576192","mri-guided-management-of-occlusive-peripheral-arterial-disease-100576192","NCT06782100","MRI Guided Management of Occlusive Peripheral Arterial Disease","Inclusion Criteria:\n\nA. General Inclusion Criteria:\n\ni. All patients will be ≥ 18 years old with PAD (Rutherford Category 4, 5, 6)\n\nB. Anatomic inclusion criteria:\n\ni. At least 1 target lesion below-the-knee in native vessels in one or both limbs ii. Target lesion reference vessel diameter between 2.0 - 4.0 mm by investigator visual estimate iii. Target lesion with \\> 50% stenosis by investigator visual estimate\n\nExclusion Criteria:\n\nA. General Exclusion Criteria:\n\ni. Rutherford category 0, 1, 2, 3 of target limb, Failure or refusal to provide written informed consent, MRI Contraindications\n\nB. Anatomic Exclusion Criteria:\n\nii. Aim 2 only - Chronic total occlusions",{"count":267,"type":21},175,"12 Months","The goal of this observational study is to identify which plaque lesions in patients with peripheral arterial disease are impenetrable and to determine which devices minimize vessel wall injury.\n\nPatients undergoing intervention will have an MRI scan prior to their planned percutaneous vascular intervention to assess the plaque and predict procedural difficulty.\n\nPatients undergoing lower limb amputation due to peripheral arterial disease will have their limbs included into a second arm of the study The limb will undergo an MRI scan to assess the plaque. The investigator will then test two different devices and assess the effects of these devices on the vessel wall.",[27],[264,272,89,273,274,275],"PAD","PVI","MRI","MRA","2026-03-16",{"date":278,"type":38},"2026-03-19",{"date":280,"type":38},"2024-07-01",{"date":282,"type":21},"2029-06",{"name":284,"class":45},"The Methodist Hospital Research Institute",{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":289,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":292,"briefSummary":218,"conditions":293,"keywords":294,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":301,"locationsCount":46},"100433333","examining-the-impact-of-exercise-training-on-vascular-dysfunction-in-individuals-with-mental-health-disorders---study-2-100433333","NCT04922762","Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 2",{"count":291,"type":21},360,[24],[27],[29,30,31,32,33],"2025-11-13",{"date":297,"type":38},"2025-11-17",{"date":299,"type":38},"2021-12-06",{"date":71,"type":21},{"name":44,"class":45},{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":310,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":313,"conditions":314,"keywords":321,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":333},"100433671","safety-performance-and-usability-of-balt-medical-devices-the-evidence-post-marketing-clinical-follow-up-platform-100433671","NCT04927156","Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform","Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform. An International, Multicenter, Prospective, and Retrospective Data Collection","EVIDENCE","Inclusion Criteria:\n\n* Provision of a signed, written and dated informed consent or non-opposition (where applicable)\n\nExclusion Criteria\n\n* Device(s) used in multiple procedures (two, or more, pathologies treated during the same procedure)\n* Contra-indications of each device as described in the instructions for use.","2 Years",{"count":312,"type":21},10000,"BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.\n\nThis platform is purely exploratory, without hierarchical order of the objectives and associated outcomes.",[315,316,317,27,318,319,320],"Intracranial Aneurysm","Brain Arterial Disease","Acute Ischemic Stroke","AVM - Cerebral Arteriovenous Malformation","AVM","Fistulas Arteriovenous",[322,323],"catheter","guidewire","2025-09-16",{"date":326,"type":38},"2025-09-18",{"date":328,"type":38},"2021-07-12",{"date":330,"type":21},"2041-10",{"name":332,"class":122},"Balt Extrusion",12,{"id":335,"slug":336,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":46},"100363779","the-mechanical-characterisation-of-human-saphenous-and-popliteal-vein-100363779","NCT04016649","The Mechanical Characterisation of Human Saphenous and Popliteal Vein","Inclusion Criteria:\n\n* Male or Female patients aged 18 years or older\n* Patients undergoing varicose vein procedures or;\n* Patients undergoing lower limb amputation or;\n* Patients undergoing lower limb bypass surgery\n\nExclusion Criteria:\n\n* Patients unable to give informed consent\n* Seriously ill\u002Funconscious patients",{"count":341,"type":21},50,"Non-interventional study aiming to ascertain the mechanical properties of human saphenous and popliteal vein tissue.",[27],{"date":345,"type":38},"2025-04-17",{"date":347,"type":38},"2019-01-21",{"date":349,"type":21},"2027-03-21",{"name":351,"class":45},"University Hospital of Limerick",{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":22,"phases":361,"briefSummary":362,"conditions":363,"keywords":367,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":46},"100579699","heat-therapy-and-peripheral-artery-disease-100579699","NCT06827691","Heat Therapy and Peripheral Artery Disease","Heat Therapy for People with Peripheral Artery Disease: a Randomised Wait-List Controlled Feasibility Trial.","Inclusion Criteria:\n\n* • Aged \\> 18 years\n\n  * ABPI \\\u003C 0.9 at rest or a drop of 20mmHG after exercise testing\n  * Diagnosed with IC\n  * Able to walk unaided\n  * English-speaking and able to follow instructions\n  * No previous history of heat syncope\n  * Post-Menopausal or not on hormone therapy\n  * Able to provide informed consent\n\nExclusion Criteria:\n\n* • Walking impairment for a reason other than PAD\n\n  * Critical limb ischaemia\u002Frest pain\n  * Asymptomatic PAD\n  * Active cancer treatment\n  * Clinically diagnosed diabetes or those with peripheral neuropathy\n  * Recent \u002F frequent heat exposure (e.g., sauna or hot tubs).\n  * severe aortic stenosis, unstable angina, recent MI, stroke or TIA",{"count":360,"type":21},70,[24],"The purpose of the study is to assess the efficacy of a novel 8 week heat therapy intervention in intermittent claudication compared to usual care controls. Participants will be enrolled on a wait-list control randomised trial testing physiological, mechanistic, and health related outcome measures.",[63,364,365,366,27],"Cardiovascular Health","Vascular Function","Intermittent Claudication",[368,369,370,371],"heat therapy","cardiovascular health","endothelial function","heat intervention","2025-02-10",{"date":374,"type":38},"2025-02-14",{"date":376,"type":21},"2025-05-01",{"date":378,"type":21},"2028-01-01",{"name":380,"class":45},"Manchester Metropolitan University",{"id":382,"slug":383,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":149,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":4},"100572636","single-arm-prospective-open-label-multi-center-clinical-investigation-for-the-demax-guide-wire-100572636","NCT06735846","Single Arm, Prospective, Open-label, Multi-center Clinical Investigation for the Demax Guide Wire","Clinical Investigation to Evaluate the Safety and Performance of Demax Guide Wire","SPOMCIDGW","Inclusion Criteria:\n\n1. Age is 18 years old or older\n2. Written consent to participate in the study\n3. All subjects must be candidates to undergo percutaneous peripheral or coronary diagnostic or interventional procedures where use of a Guide Wire is indicated.\n4. Eligible for catheter-based diagnostic or treatment procedure. A representative list of diseases and catheter-based treatments includes:\n\n   Suspicion of obstructive coronary artery disease manifest as myocardial infarction, angina pectoris, angina-equivalent, ischemic dysrhythmia, or evidence of ischemia or viability on non-invasive cardiovascular testing Suspicion of peripheral vascular obstructive disease undergoing elective or urgent diagnostic and\u002For percutaneous therapeutic procedures.\n5. Palpable pulse of the proximal and distal radial artery on one or both arms\n6. Subjects must be suitable for a transfemoral vascular access\n7. Subjects undergoing elective or urgent percutaneous treatment of symptomatic arterial occlusive disease and intermittent claudication or CLI of the SFA and\u002For popliteal arteries.\n8. Subjects with suspected narrowed or blocked arteries in the heart.\n\nExclusion Criteria:\n\n1. Inability to provide consent\n2. Pregnant or lactating women\n3. Subjects actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period.\n4. Subjects with bilateral hand or arm misalignment \u002F paresis that makes a radial access impossible\n5. Subject has a known allergy to the Guide Wire materials\n6. Subjects with emergent procedures acute ischemia, aneurysmal disease, common femoral or profunda interventions, or hybrid procedures were excluded.\n7. Subjects with severe infections\n8. Subjects with severe heart failure\n9. Subjects with severe physical weakness",{"count":390,"type":21},100,[24],"The objectives of this study are to confirm the safety and performance of the Guide Wire when used in patients with peripheral vascular or coronary vascular disease for diagnostic or treatment procedures and will be the pivotal trial for this device. This study intends to evaluate the Guide Wire in its ability to successfully deploy an intended diagnostic or therapeutic catheter according to the IFU without any device related deficiencies, time to reach a specified position, and total number of insertion attempts to reach a primary performance endpoint.",[27,394],"Coronary Artery Disease","2024-12-11",{"date":397,"type":38},"2024-12-16",{"date":399,"type":21},"2025-03",{"date":401,"type":21},"2025-07",{"name":403,"class":122},"DemaxGroup",{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":133,"enrollmentInfo":412,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":414,"conditions":415,"keywords":418,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":428,"locationsCount":430},"100564243","vascular-regenerative-cell-exhaustion-in-adults-with-peripheral-artery-disease-pad-vrce-100564243","NCT06626646","Vascular Regenerative Cell Exhaustion in Adults with Peripheral Artery Disease (PAD-VRCE)","Vascular Regenerative Cell Exhaustion in Adults with Peripheral Artery Disease","PAD-VRCE","Inclusion Criteria:\n\n1. Adults ≥18 and ≤80 years of age who meet either of the following criteria:\n\n   1. Clinically significant\u002Fsymptomatic PAD (defined as symptomatic claudication with and an ankle brachial index of less than 0.85).\n   2. No history of PAD.\n2. Willing and able to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n1. Unable or unwilling to provide written informed consent or to provide a peripheral blood sample.\n2. Any life-threatening disease expected to result in death within two years.\n3. Any malignancy not considered cured (except basal cell carcinoma of the skin). An individual is considered cured if there has been no evidence of cancer recurrence for the five years prior to screening.\n4. Uncontrolled hypertension.\n5. New York Heart Association Class IV heart failure.\n6. Active liver disease or liver dysfunction.\n7. Active kidney disease or kidney dysfunction.\n8. History of hemorrhagic stroke or other major bleeding disorder.\n9. White blood cell count of ≥15x10\\^9\u002FL.\n10. Active infectious disease requiring systemic antibiotic or anti-viral agents.\n11. Known acquired immunodeficiency syndrome, such as Human Immunodeficiency Virus.\n12. On oral steroid therapy (e.g. prednisone or other corticosteroids) or other immunosuppressive agents (e.g. methotrexate).\n13. Treated autoimmune disorders",{"count":413,"type":21},40,"PAD-VRCE is an observational, cross-sectional, two arm study aimed at determining if the presence of peripheral artery disease (PAD) can influence the number of circulating regenerative cells in blood. From peripheral blood samples, circulating progenitor cell content will be assessed via flow cytometry and compared between individuals with PAD and individuals without PAD. Ultimately, this study plans to evaluate the relationship between PAD, vascular regenerative cell exhaustion and overall cardiovascular health.",[27,416,417,62],"Cardiovascular Disease","Type 2 Diabetes",[419,420,421],"Progenitor cells","Cardiovascular disease","Peripheral artery disease","2024-10-02",{"date":424,"type":38},"2024-10-04",{"date":426,"type":21},"2024-10",{"date":401,"type":21},{"name":429,"class":45},"Canadian Medical and Surgical Knowledge Translation Research Group",2]