[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peripheral-arterial-occlusive-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peripheral-arterial-occlusive-disease":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,72,103,125,155],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100540630","early-phase-1-impact-of-nrf2-activation-on-macrovascular-microvascular--leg-function--walking-capacity-in-peripheral-artery-disease-100540630",false,"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,"ALL","50 Years","75 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31],"Peripheral Artery Disease","Peripheral Vascular Diseases","Peripheral Arterial Disease","Peripheral Arterial Occlusive Disease","RECRUITING","2026-06-19",{"date":35,"type":36},"2026-06-24","ACTUAL",{"date":38,"type":36},"2024-11-14",{"date":40,"type":22},"2026-12",{"name":42,"class":43},"University of Nebraska","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100620067","phase-2-safety-of-antithrombotic-heparin-proteoglycan-mimetic-apac-in-peripheral-arterial-occlusive-disease-and-chronic-limb-threatening-ischemia-100620067","NCT07352800","Safety of Antithrombotic Heparin Proteoglycan Mimetic APAC in Peripheral Arterial Occlusive Disease and Chronic Limb-threatening Ischemia","A Phase 2a Open-label Study to Assess the Safety, Tolerability, and Dosing Regimen of Antithrombotic Heparin Proteoglycan Mimetic APAC in Patients With Peripheral Arterial Occlusive Disease and Chronic Limb-threatening Ischemia Undergoing Endovascular Revascularization","HEALING","Inclusion Criteria (Parts A1, B1 and B2):\n\n1. Males aged 45-85 years and postmenopausal females (i.e., no menstrual periods for 12 months without an alternative medical cause) up to 85 years.\n2. Diagnosed with a. PAOD classification Fontaine stage III or IV , b. the total length of the treatment-targeted arterial segment ≥ 5 cm below the knee lesion(s) based on contrast-enhanced computed tomography angiography (CTA)\u002Fmagnetic resonance angiography (MRA)\u002Fdigital subtraction angiography (DSA) (Part B1 and B2), c. superficial forefoot wounds without overt infection and bone invasion (WIfI 0-1 and 2 limited to digits and WIfI infection 0-1) allowed, d. undergoing endovascular intervention. (In Part A1, if prescheduled endovascular intervention would take place before the Day 8 study visit, patient is not to be enrolled.)\n3. CTA\u002FMRA\u002FDSA with contrast agent performed within 3 months prior to study enrolment as part of diagnostics of PAOD, with results available in the patient's medical records.\n4. Patients should be treated with antithrombotic medication either acetylsalicylic acid (up to 100 mg once a day \\[QD\\]) or clopidogrel (up to 75 mg QD) for at least the preceding five days before the first APAC administration.\n5. Adequate lipid lowering therapy, as evaluated by the investigator.\n6. Capability and willingness to provide valid, voluntary written informed consent for the study.\n7. Males must be willing to use a condom and their female partners of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile \\[hysterectomy, bilateral salpingectomy and bilateral oophorectomy\\]) must be willing to use highly effective contraception while on study treatment. Highly effective methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; and sexual abstinence.\n8. Males must refrain from sperm donation while on study treatment.\n\nInclusion Criteria (Part A2):\n\n1. Males aged 45-85 years and postmenopausal females (i.e., no menstrual periods for 12 months without an alternative medical cause) up to 85 years.\n2. Diagnosed with a. PAOD classification Fontaine stage IIa and IIb, b. not prescheduled for endovascular revascularization within 90 days of first APAC administration.\n3. Moderate to severe arterial disease, ABI \\\u003C 0.7.\n4. Patients should be capable of performing evaluable treadmill exercise test.\n5. Patients should be treated with antithrombotic medication either acetylsalicylic acid (up to 100 mg QD) or clopidogrel (up to 75 mg QD) for at least the preceding five days before the first APAC administration.\n6. Adequate lipid lowering therapy, as evaluated by the investigator.\n7. Capability and willingness to provide valid, voluntary written informed consent for the study.\n8. Males must be willing to use a condom and their female partners of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile \\[hysterectomy, bilateral salpingectomy and bilateral oophorectomy\\]) must be willing to use highly effective contraception while on study treatment. Highly effective methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable); IUD; IUS; bilateral tubal occlusion; vasectomized partner; and sexual abstinence.\n9. Males must refrain from sperm donation while on study treatment.\n\nExclusion Criteria:\n\n1. Any ischemic lesions of the heel and midfoot and lesions (wounds or gangrene) invading bones, joints, or tendons at metatarsophalangeal joints or more proximal sites.\n2. Acute limb-threatening ischemia (e.g., thromboembolic disease).\n3. Medical history of, or an existing aneurysm.\n4. Endovascular revascularization intervention is done from the contralateral side using cross-over access (Part B1 and B2).\n5. Medical history of, or condition known to be associated with impaired hemostasis, i.e., increased intracranial bleeding risk e.g., previous history of intracranial hemorrhage, subarachnoidal bleeding, hemorrhagic stroke, thrombotic or thromboembolic stroke, gastrointestinal bleeding within 6 months of enrolment, or retroperitoneal bleeding any time, or any inherited or acquired bleeding disorder, i.e., von Willebrand disease or hemophilia or other relevant diagnosis causing impaired hemostasis.\n6. Current use of therapeutic dose of anticoagulation (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban, fondaparinux, or any heparin derivative) for any medical reason. (Use of dual pathway inhibition \\[= acetylsalicylic acid 100 mg + rivaroxabahn 2.5 mg x 2\\] is not a contraindication, but will be temporarily halted for the day of intervention and day of repeating dosing)\n7. Patients treated with combined antiplatelet agents: aspirin + P2Y12 antagonist (clopidogrel, ticagrelor, prasugrel).\n8. Diagnosis of autoimmune diabetes mellitus (Type 1 diabetes, or latent autoimmune diabetes in adults \\[LADA\\]) vasculitis, rheumatoid arthritis, inflammatory bowel diseases, or other general autoimmune diseases.\n9. Body mass index \\> 35 kg\u002Fm\\^2.\n10. Patients with clinically significant acute infection, as judged by the investigator.\n11. Use of non-steroidal anti-inflammatory medications within 2 weeks prior to the first dose of APAC or during the treatment period. If medication for pain is required, paracetamol or tramadol (e.g. an opioid patch) may be used.\n12. Use of selective serotonin reuptake inhibitor (SSRI) medication within 2 weeks prior to the first dose of APAC or during the treatment period.\n13. Peroral use of glycosaminoglycans or omega 3 or related products within 28 days before IMP treatment.\n14. Major surgery, major trauma or any endovascular intervention within the past 90 days or organ biopsy prior to the screening visit or scheduled for such an intervention during the study.\n15. Uncontrolled arterial hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg).\n16. Blood hemoglobin concentration \\\u003C120 g\u002FL or \\> 170 g\u002FL (men) and \\\u003C110 g\u002FL or \\>160 g\u002FL (women) at screening.\n17. Blood platelet count \\\u003C150 x 10\\^9\u002FL or \\> 450 x10\\^9\u002FL and\u002For leukocyte count in the lower reference range or not above \\>12 x 10\\^9\u002FL.\n18. Clinically significantly prolonged plasma PT (\\> 1.2-fold) or a value of less than 50% (when normal reference range is 70-130%).\n19. APTT above the upper limit of the reference range.\n20. Patients with a medical history of heparin-induced thrombocytopenia.\n21. Patients with known significant liver disease, incl. an alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) level \\> 2.5 x the upper limit of normal (ULN) at screening.\n22. A diagnosis of severe chronic kidney disease, defined as having an eGFR category 4 or 5 (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 as per calculation of Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\]) or albuminuria stage A3 (uACR \\>300 mg\u002Fg).\n23. Patients with an active malignancy, or who have received treatment for any malignancy including bone marrow transplantation within 5 years before the screening visit, except for localized basal cell or squamous cell skin cancer that has been cured at least 90 days before screening.\n24. Previous treatment with APAC.\n25. Patients with known allergy or hypersensitivity to heparin, or heparin products, APAC, and\u002For antiplatelet agents (e.g., aspirin or clopidogrel), and protamine sulphate, the reversal agent for APAC.\n26. Participation in an investigational drug or device study within 90 days prior to screening.\n27. Patients who have ever received treatment with a gene therapy.\n28. Patients with known antiphospholipid antibody syndrome or other known significant thrombophilia (homozygosity for FV Leiden or FIIG20210A mutation, or phospholipid antibody syndrome, deficiency of antithrombin, protein C or protein S or combined thrombophilia).\n29. Any concomitant disease or condition or treatment that could interfere with, or the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study as judged by the investigator.\n30. Patients with severe comorbidities and limited life expectancy as judged by the investigator.\n31. Patients unable or unwilling to comply with the protocol or to cooperate fully with the investigator or site personnel.\n32. Patients with current and\u002For history of drug abuse (defined as illicit drug use) or alcohol abuse (defined as daily consumption of more than 23-24 and 12-16 alcoholic drinks per week in males and females, respectively).","85 Years",{"count":55,"type":22},42,[57],"PHASE2","The goal of this study is to learn if a new medicine (called antiplatelet and anticoagulant \\[APAC\\]) can help the body to prevent blood clots and whether APAC is safe and well tolerated in patients with blocked or narrowed arteries in their legs (peripheral arterial occlusive disease \\[PAOD\\]), and in patients with severely restricted poor blood flow to the legs that threatens limb health (chronic limb-threatening ischemia \\[CTLI\\]). The study also aims to find the best dose of the medicine. The study consists of two parts: Part A will include patients with PAOD and CTLI, Part B will only include patients with CTLI who are having a procedure to restore blood flow in their legs. Both parts will be subdivided into two subgroups (A1 and A2, B1 and B2) which will test different APAC doses and compare single dosing to weekly dosing for 4 weeks. APAC is injected into the blood. The possible treatment response will be compared either to a placebo (a look-alike substance that contains no drug), or to the current standard treatment. Patients will participate in the study for up to 90 or 180 days. During this time, patients will be regularly examined and asked to answer questions concerning their quality of life.",[31,60],"Chronic Limb-Threatening Ischemia","2026-04-08",{"date":63,"type":36},"2026-04-09",{"date":65,"type":36},"2026-01-29",{"date":67,"type":22},"2027-06-30",{"name":69,"class":70},"Aplagon Oy","INDUSTRY",3,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100591410","wearable-devices-assist-in-the-detection-screening-and-management-of-major-diseases-in-middle-aged-and-elderly-populations-100591410","NCT06980064","Wearable Devices Assist in the Detection, Screening, and Management of Major Diseases in Middle-aged and Elderly Populations","Wearable Devices Assist in the Detection, Screening, and Management of Major Diseases in Middle-aged and Elderly Populations: a Multicenter Randomized Controlled Trial","The inclusion criteria are as follows:\n\n1. Aged more than equal to 40 years, less than 69 years.\n2. Having at least one of the following conditions (with one risk factor for cardiovascular and cerebrovascular diseases):\n\n   ① Male ≥ 55 years old, female ≥ 65 years old; ② Smokers or those who quit smoking within the past 3 months prior to the visit; ③ Diabetes (type 1 or 2); ④ Hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg) or currently taking antihypertensive medication; ⑤ Dyslipidemia: total cholesterol ≥ 5.18mmol\u002FL, triglycerides ≥ 1.70mmol\u002FL, high-density lipoprotein\\\u003C1.04mmol or low-density lipoprotein ≥ 3.37mmol\u002FL; ⑥ hsCRP\\>3.0 mg\u002FL; ⑦ 10-year ASCVD risk of 20% or more (calculated according to the formula designed in the PREVENT study)\n3. Agree to receive coronary CTA if suspected to have coronary artery stenosis.\n4. Voluntarily joined and signed the informed consent.\n\nThe exclusion criteria:\n\n1. Previously diagnosed with CAD or considered moderate to severe coronary stenosis (CAD-RADS grade 3 or above: stenosis degree of 50% or above) through coronary CTA or coronary angiography examination.\n2. Pregnant women or women planning to become pregnant within the next year.\n3. During the onset of the disease and needs in-hospital treatment.\n4. Tattoos or other substances that affect optical signals on the wrist.\n5. Severe arrhythmia patients, including third degree atrioventricular block, ventricular escape rhythm, severe sinus bradycardia, sick sinus syndrome, supraventricular tachycardia, ventricular tachycardia, atrial fibrillation, atrial flutter, ventricular fibrillation, ventricular flutter.\n6. Physical disability, blindness, and deafness.\n7. Allergic history of contrast agent containing iodine.","40 Years","69 Years",{"count":82,"type":22},800,[84],"NA","The goal of this randomized controlled trial is to evaluate the effectiveness of wearable devices (Huawei smartwatches) in aiding the detection, and screening of major diseases (e.g., coronary artery disease, hypertension) in middle-aged and elderly populations aged 40-69 years with cardiovascular risk factors (e.g., smoking, diabetes, hypertension, dyslipidemia). The main questions it aims to answer are:\n\nDoes AI-assisted diagnosis using wearable device data improve the detection rate of coronary artery stenosis (CAD-RADS ≥3) compared to standard physician assessment without AI assistance?\n\nDoes the intervention reduce the incidence of coronary artery disease-related events (e.g., angina, myocardial infarction) within one year?\n\nResearchers will compare the intervention group (AI model-assisted diagnosis based on Huawei smartwatch data) with the control group (standard assessment) to determine if the AI-aided smartwatch approach enhances diagnostic accuracy and clinical outcomes.\n\nParticipants will:\n\n（Intervention group）Wear a Huawei smartwatch for 24 hours to collect physiological data (e.g., PPG signals, heart rate, motion).\n\nUndergo baseline assessments, including medical history review, physical exams, and laboratory tests.\n\nReceive a preliminary diagnosis from a general practitioner.\n\nComplete a follow-up evaluation after one year to track cardiovascular events and other disease outcomes.\n\nUndergo coronary CTA if suspected of coronary stenosis.",[87,88,89,90,91,31,92],"Coronary Stenosis","Cerebral Arterial Diseases","Hypertension","Parkinson Disease","Heart Failure","Thyroid Dysfunction","NOT_YET_RECRUITING","2025-05-16",{"date":96,"type":36},"2025-05-20",{"date":98,"type":22},"2025-06-01",{"date":100,"type":22},"2026-12-31",{"name":102,"class":43},"Tongji Hospital",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":16,"sex":17,"minAge":79,"maxAge":53,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":44},"100531779","early-phase-1-safety-tolerability-and-biodistribution-of-89zrzr-dfo-apac-in-subjects-with-paodcli-and-healthy-volunteers-acronyms-89zr--zirconium-89-dfo--desferrioxamine-apac--antiplatelet-anticoagulant-petct--positron-emission-tomographycomputed-tomography-100531779","NCT06204237","Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC in Subjects With PAOD\u002FCLI and Healthy Volunteers (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET\u002FCT = Positron Emission Tomography\u002FComputed Tomography)","Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC (Phase 0) in Subjects With Peripheral Arterial Occlusive Disease \u002F Critical Limb Ischemia (PAOD\u002FCLI) and Healthy Volunteers - an Open Label PET Study (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET\u002FCT = Positron Emission Tomography\u002FComputed Tomography)","CHASE","INCLUSION CRITERIA PATIENTS\n\n1. Males and females aged 40-85 years.\n2. PAOD\u002FCLI patients Rutherford categories 1-4 and category 5 with Wlfl wound grade of 0 or 1.\n3. Estimated glomerular filtration rate (eGFR) \\>46 mL\u002Fmin\u002F1.73 m2 as per calculation of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).\n4. CT angiography with contrast agent performed of within 3 months of the patients' first PET-scan as part of diagnostics of PAOD, with results available in the subject's medical records.\n5. No surgical or endovascular intervention for PAOD within 1 year of the first PET\u002FCT-scan or planned between inclusion and the patients' last PET-scan.\n6. Provision of valid informed consent and capability to communicate well with the investigator.\n7. Pre-menopausal woman must be willing to practise highly effective contraception for 195 days after IMP administration.\n8. Men must be willing to practise highly effective contraception for 105 days after IMP administration, including condom use during the first 15 days to prevent transmission of 89-Zr to a partner of childbearing potential.\n9. Patients should be able to understand all study-related information in Dutch.\n\nEXCLUSION CRITERIA PATIENTS\n\n1. Acute limb-threatening ischemia (e.g., embolic disease).\n2. An existing aneurysm that requires surgical intervention.\n3. Medical history of, or condition known to be associated with impaired hemostasis, such as an increased intracranial bleeding risk e.g., previous history of intracranial hemorrhage, subarachnoidal bleeding, hemorrhagic stroke, or gastrointestinal or retroperitoneal bleeding, or any inherited or acquired bleeding disorder, such as von Willebrand disease or hemophilia.\n4. Any cerebrovascular event (including transient ischemic attack, thrombotic or embolic stroke) within the past year.\n5. Diagnosis of autoimmune (Type 1, or latent autoimmune diabetes in adults (LADA))diabetes mellitus.\n6. HbA1c \\>10% at screening.\n7. Current use of anticoagulant therapy (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban, fondaparinux, or any heparin derivative) for any medical reason.\n8. Patients treated with combined antiplatelet agents, excluding a single agent, such as acetylsalicylic acid (up to 100 mg QD) or clopidogrel (up to 75 mg QD).\n9. Use of non-steroidal anti-inflammatory medications within 2 weeks prior to dosing with \\[89Zr\\]Zr-DFO-APAC. If pain relief is required, paracetamol may be used.\n10. Use of selective serotonin reuptake inhibitor (SSRI) medications within 2 weeks prior to dosing with \\[89Zr\\]Zr-DFO-APAC.\n11. Major surgery, major trauma or any endovascular intervention within the past 90 days or organ biopsy or diagnostic angiography within the past 30 days prior to the screening visit.\n12. Uncontrolled arterial hypertension (persistent systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg).\n13. Hemoglobin \\\u003C8.0 mmol\u002FL (130 g\u002Fl) (men) or \\\u003C7.5 mmol\u002FL (120 g\u002Fl) (women) at screening, or platelet count \\\u003C150 x 109\u002FL and leukocyte count \\>12 x 109\u002FL.\n14. Clinically significantly prolonged plasma prothrombin time (PT) and activated plasma partial thromboplastin time (APTT) (\\> 1.2-fold).\n15. Patients with a medical history of heparin-induced thrombocytopenia.\n16. Patients with known significant liver disease, incl. an alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) level \\> 2.5 x ULN (Upper limit normal) at screening.\n17. A diagnosis of severe chronic kidney disease, defined as having a glomerular filtration rate (GFR) category 4 or 5 (GFR ≤ 45 mL\u002Fmin\u002F1.73 m2) and albuminuria stage A3 albumin:creatinine ratio (ACR) of \\>300 mg\u002Fg).\n18. Patients with an active malignancy or who have received treatment for any malignancy within 1 year before the screening visit, except for localized basal cell or squamous cell skin cancer that has been cured at least 90 days before screening.\n19. Patients with a history of metastatic malignancy.\n20. Women who are pregnant or lactating.\n21. Patients with a known allergy or hypersensitivity to heparin or heparin products, and\u002For antiplatelet agents (e.g., aspirin or clopidogrel).\n22. Participation in an investigational drug or device study within 30 days prior to screening.\n23. Patients who have ever received treatment with an antibody or gene therapy product or participated in a clinical trial with such agents (unless there is evidence that they received placebo only).\n24. Patients with known antiphospholipid antibody syndrome or other thrombophilia.\n25. Patients with a medical history of severe infection or vasculitis due to an autoimmune disease, inflammatory bowel disease (IBD) or Crohn's disease.\n26. Any concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject.\n27. Patients unable or unwilling to comply with the protocol or to cooperate fully with the investigator or site personnel.\n28. Patients with anamnestic history of drug abuse (defined as illicit drug use) or anamnestic history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 12 months.\n\nINCLUSION CRITERIA HEALTHY VOLUNTEERS\n\n1. Male or female volunteers 40-80 years old, inclusive.\n2. Healthy status defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis.\n3. No diagnosis of diabetes, pre-diabetes or insulin resistance.\n4. Normal eGFR as per calculation of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).\n5. Premenopausal woman must be willing to practise highly effective contraception for 195 days after IMP administration.\n6. Men must be willing to practise highly effective contraception for 105 days after IMP administration, including condom use during the first 15 days to prevent transmission of 89-Zr to a partner of childbearing potential\n7. Healthy volunteers should be able to understand all study-related information in Dutch.\n\nEXCLUSION CRITERIA HEALTY VOLUNTEERS\n\n1. Any sign or symptom of PAOD\u002FCLI or other cardiovascular disease.\n2. Abnormal ankle-brachial index (ABI) at rest and\u002For decrease of ABI following treadmill exercise.\n3. Use of any anticoagulant or antiplatelet (not including aspirin at recommended doses) agent within the recent 12 months before screening.\n4. Any regular prescription or over-the-counter medication, except for vitamins.\n5. Medical history of heparin-induced thrombocytopenia.\n6. Medical history of atrial fibrillation and\u002For those with a mechanical heart valve.\n7. Major surgery, major trauma or organ biopsy within the past 90 days before screening.\n8. Medical history of, or any condition, associated with an increased bleeding risk.\n9. Arterial hypertension (systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg.\n10. Subjects with a medical history of, or an existing aneurysm.\n11. Hemoglobin \\\u003C8.0 mmol\u002FL (130 g\u002Fl) (men) or \\\u003C7.5 mmol\u002FL (120 g\u002Fl) (women) at screening or platelet count \\< 150 x 109\u002FL or leukocyte count above normal (12 x 109\u002FL).\n12. Clinically significantly prolonged prothrombin time (PT) and activated partial thromboplastin time (APTT) (\\> 1.2-fold).\n13. Participation in an investigational drug or device study within 30 days prior to screening.\n14. Subjects who have ever received treatment with an antibody or gene therapy product or participated in a clinical trial with such agents (unless there is evidence that they were received placebo only).\n15. Subjects with known thrombophilia.\n16. Women who are pregnant or lactating.\n17. Subjects unable or unwilling to comply with the protocol or to cooperate fully with the investigator or site personnel.\n18. Subjects with anamnestic history of drug abuse (defined as illicit drug use) or a anamnestic history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 3 months.",{"count":112,"type":22},10,[25],"The goal of this Phase 0 clinical trial is to evaluate safety and biodistribution of \\[89Zr\\]Zr-DFO-APAC in patients with peripheral arterial occlusive disease \u002F critical limb ischemia (PAOD\u002FCLI) and healthy volunteers. The main questions it aims to answer are:\n\n* What is the safety, tolerability and pharmacokinetic profile (PK: both systemic and local vascular injury site-specific PK) of \\[89Zr\\]Zr-DFO-APAC?\n* What is the biodistribution and internal radiation dosimetry of the tracer dose of \\[89Zr\\]Zr-DFO-APAC?\n* What is the binding and retention time of \\[89Zr\\]Zr-DFO-APAC to arteries and atherosclerotic or microvascular lesions? Participants will receive a dose of the \\[89Zr\\]Zr-DFO-APAC (IMP) and PET\u002FCT imaging is performed on days 1, 3 and 7, and follow-up visit 7-14 days post IMP dosing.",[31,116],"Critical Limb Ischemia","2025-01-28",{"date":119,"type":36},"2025-01-30",{"date":121,"type":36},"2024-02-01",{"date":123,"type":22},"2025-06",{"name":69,"class":70},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":132,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":136,"conditions":137,"keywords":142,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":44},"100522426","framed-infrainguinal-venous-bypass-versus-conventional-autologous-bypass-trial-100522426","NCT06082466","FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial","Framed IVB","Inclusion Criteria\n\n* Age at least 18 years\n* Informed consent form with signature\n* Rutherford Category 3 (\\\u003C200m) or chronic critical ischemia (Rutherford Category 4-6)\n* Assured inflow and recipient artery.\n\nExclusion Criteria\n\n* Pregnant or breastfeeding women\n* Active infection or sepsis\n* Acute ischemia\n* Endovascular procedure in the region to be treated.\n* Vein with outer diameter \\\u003C3.5 mm or \\>8 mm under pressure.\n* Spliced Veins.\n* Known allergy to the cobalt-chromium alloy (ASTM 1058) or its components (Cobalt-Chromium-Iron-Nickel-Molybdenum).\n* Vasculitis\n* Coagulopathy\n* Radiation therapy near the anastomosis","18 Years",{"count":134,"type":22},110,[84],"The purpose of this clinical trial is to analyze patency after autologous infrainguinal bypass surgery in patients receiving a venous conduit versus a covered venous conduit.",[31,138,139,140,141],"Femoropopliteal Artery Occlusion","Femoropopliteal Stenosis","Critical Limb-Threatening Ischemia","Claudication, Intermittent",[143,144,145],"Extraluminal Bypass Stenting","Autologous Vein Graft","Bypass Extremity Graft","2023-11-20",{"date":148,"type":36},"2023-11-21",{"date":150,"type":36},"2023-09-11",{"date":152,"type":22},"2027-09",{"name":154,"class":43},"Paracelsus Medical University",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":132,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":44},"100510998","efficacy-and-safety-of-the-regulatory-polypeptides-in-patients-with-peripheral-atherosclerosis-100510998","NCT05933720","Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis.","Evaluation of the Efficacy and Safety of the Drug Based on Vascular Regulatory Polypeptides for the Treatment of Patients With Lower Extremity Atherosclerotic Arterial Occlusive Disease.","Inclusion Criteria:\n\nmen or women over 18 years of age with lower extremity atherosclerotic arterial occlusive disease, confirmed with instrumental work-up methods (ultrasonography or angiography).\n\nExclusion Criteria:\n\nmen or women under 18 years of age; history of anaphylaxis; hypersensitivity to any of the components that make up the drug Slavinorm®, and proteins of animal origin; absolute and relative contraindications to the treadmill test; failure to walk at a minimum speed of 3.2 km\u002Fh (2 mph) at a minimum treadmill angle for at least 2 minutes during the stress test during the screening phase; depression of the ST segment more than 1 mm in one or more standard leads on the electrocardiogram; peripheral artery disease not associated with atherosclerosis; patients who underwent reconstructive surgery or invasive interventions on the arteries of the lower extremities in history without a clinic of intermittent claudication; angina pectoris III-IV functional class (FC) according to the CCS classification; body mass index \\>35 kg\u002Fm2; acute or chronic renal (creatinine clearance less than 30 ml \u002F min) and \u002F or liver failure \\[aspartate aminotransferase (AST), alanine aminotransferase (ALT) \\> 3 times the upper limit of normal\\]; chronic heart failure III-IV FC according to NYHA; acute coronary syndrome within 6 months. before the start of the screening period; any clinically significant condition or comorbidity that, in the opinion of the Investigator, would preclude the patient from participating in the study.","80 Years",{"count":164,"type":22},120,[84],"The study is aimed at assessing the role of the activity of markers of endothelial dysfunction (cytotoxic malonic aldehyde (MDA), angiotensin II, endothelial nitric oxide synthase (NO), endothelin-1, prostacyclin) in the systemic circulation in patients with lower extremity atherosclerotic arterial occlusive disease undergoing open reconstructive interventions.",[31],[30,169,170],"bypass grafting","polypeptides","2023-06-27",{"date":173,"type":36},"2023-07-06",{"date":175,"type":36},"2023-04-01",{"date":177,"type":22},"2026-09-01",{"name":179,"class":43},"Ryazan State Medical University"]