[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"femoropopliteal-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:femoropopliteal-stenosis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100407377","the-efemoral-vascular-scaffold-system-evss-for-the-treatment-of-patients-with-symptomatic-peripheral-vascular-disease-from-stenosis-or-occlusion-of-the-femoropopliteal-artery-100407377",false,"NCT04584632","The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery","A Clinical Evaluation of the Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery","Efemoral I","Inclusion Criteria:\n\n* Symptomatic peripheral vascular occlusive disease (Rutherford-Becker Clinical Category 2-4)\n* Patient with life expectancy \\>36 months\n* Females of childbearing potential must have negative pregnancy test\n* Patient is able to provide informed consent\n* Patient agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.\n* Patient must be able to take antiplatelet and\u002For anticoagulant agents as prescribed\n* Single de novo native disease segment of the superficial femoral artery (SFA) or P1 popliteal segment\n* Reference vessel diameter ≥5.5 mm and ≤6.5 mm\n* Target lesion length ≤90 mm\n* Target lesion with ≥50% DS\n* Inflow artery and popliteal artery free from flow-limiting lesion (DS \\\u003C50%)\n\nExclusion Criteria:\n\n* Hemoglobin \\\u003C9.0 g\u002FdL\n* WBC \\\u003C3,000 cells\u002Fmm3\n* Platelet count \\\u003C80,000 cells\u002Fmm3 or \\>700,000 cells\u002Fmm3\n* Acute or chronic renal dysfunction with creatinine \\>2.5 mg\u002Fdl (176 µmol\u002FL)\n* Severe liver impairment as defined by total bilirubin ≥3 mg\u002Fdl or two times increase over the normal level of SGOT or SGPT\n* A known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticagrelor or sirolimus, or with contrast sensitivity for which the patient cannot be adequately pre-medicated\n* Patient requires a planned procedure that would necessitate discontinuation of antiplatelet therapy\n* Patient is unable to walk\n* Patient has undergone a percutaneous vascular intervention \\\u003C30 days prior to the planned index procedure\n* Patient is maintained on chronic hemodialysis\n* Patient has uncontrolled diabetes mellitus (HbA1c ≥7.0%).\n* Patient has had a myocardial infarction within the previous 30 days of the planned index procedure\n* Patient has had a stroke within the previous 30 days of the planned index procedure and\u002For has deficits from a prior stroke that limits the patient's ability to walk\n* Patient has unstable angina defined as rest angina with ECG changes\n* Patient has a local groin or acute systemic infection that has not been treated successfully or is currently under treatment\n* Patient has acute thrombophlebitis, deep vein thrombosis or chronic venous insufficiency in either extremity\n* Patient has other medical illnesses (e.g., cancer, congestive cardiomyopathy, etc.) that may cause the patient to be non-compliant with protocol requirements, confound the data interpretation or will prevent completion of all required follow up assessments through 36 months\n* Patient is currently participating in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints\n* Patient has ischemic or neuropathic ulcers on either foot\n* Patient has undergone minor or major amputation of either lower extremity\n* Patient is part of a vulnerable population who, in the judgment of the Investigator, is unable to give informed consent\n* Target extremity with an angiographically significant (\\>50% DS) lesion located distal to the target lesion that requires treatment at the time of the index procedure or by a staged procedure\n* Acute arterial ischemia of the target extremity\n* Target extremity has been previously treated with open surgical revascularization (bypass or endarterectomy)\n* Target vessel has been previously treated with stent, laser, atherectomy, surgical bypass, or endarterectomy\n* Total occlusion (100% DS) of the ipsilateral inflow artery\n* Angiographic evidence of thrombus in the target vessel\n* The target lesion requires treatment with a device other than percutaneous transluminal balloon angioplasty (PTA) \\[e.g., orbital atherectomy, directional atherectomy, excimer laser, rotational atherectomy, cryoplasty, etc.\\]\n* Target lesion is within or adjacent to an aneurysm\n* Patient has angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion or from crossing or pre-dilating the target lesion\n* Target lesion has moderate-to-severe calcification\n* Target lesion with \\> 30% residual stenosis following pre-dilatation","ALL",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery",[26,27,28,29],"Peripheral Arterial Disease","Vascular Diseases","Stenosis","Femoropopliteal Stenosis",[31,32],"Peripheral Artery Disease","Bioresorbable","RECRUITING","2026-03-23",{"date":36,"type":37},"2026-03-25","ACTUAL",{"date":39,"type":37},"2020-09-22",{"date":41,"type":20},"2030-03",{"name":43,"class":44},"Efemoral Medical, Inc.","INDUSTRY",8,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100536104","histological-segmentation-of-the-superficial-femoral-artery-from-microscan-to-ct-using-artificial-intelligence-100536104","NCT06260488","Histological Segmentation of the Superficial Femoral Artery From Microscan to CT Using Artificial Intelligence","Histological Segmentation of the Superficial Femoral Artery From Microscan to CT Using Artificial Intelligence: a Feasibility Study (CTPred)","CTPred","Inclusion criteria:\n\n* Male or female of legal age\n* Subject with a planned transfemoral amputation in the vascular surgery department of the Hôpitaux Universitaires de Strasbourg as standard care\n* Subject with a CT as part of standard care\n* Subject who has given his\u002Fher non-opposition to participate in the study\n\nExclusion criteria:\n\n\\- Impossible to give the subject informed information (subject in emergency situation, difficulties in understanding)",true,"18 Years",{"count":57,"type":20},20,[23],"The femoropopliteal artery segment (FPAS) is one of the longest arteries in the human body, undergoing torsion, compression, flexion and extension due to lower limb movements. Endovascular surgery is considered to be the treatment of choice for the peripheral arterial disease, the results of which depend on the physiological forces on the arterial wall, the anatomy of the vessels and the characteristics of the lesions being treated. The atheromatous disease includes, in a simple way, 3 categories of plaques: calcified, fibrous, and lipidic. The study of these plaques and their differentiation in imaging and histology in the FPAS has already been the subject of research. To treat them, there are angioplasty balloons and stents with different designs and components, with different mechanical properties and different impregnated molecules.\n\nThere is no non-invasive method (imaging) to accurately differentiate lesions along the FPAS. The analysis is performed from the preoperative CT scan, but there are high-resolution scanners that allow a quasi-histological analysis of the tissue.\n\nThis microscanner can be used ex vivo. In the framework of a project, the learning algorithm was be créated (Convolutional Neural Networks) to automatically segment microscanner slices: after taking FPAS from amputated limbs, we correlated ex-vivo microscanner images of the arteries with their histology. The correlation was then performed manually between the microscanner images, and the histological sections obtained. the algorithm well be trained on these slices and validated its performance. The validation of the CT and microscanner concordance was the subject of scientific publications.",[31,29],"2025-04-22",{"date":63,"type":37},"2025-04-25",{"date":65,"type":37},"2024-03-15",{"date":67,"type":20},"2025-08-15",{"name":69,"class":70},"University Hospital, Strasbourg, France","OTHER",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":71},"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",{"count":80,"type":20},110,[23],"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.",[84,85,29,86,87],"Peripheral Arterial Occlusive Disease","Femoropopliteal Artery Occlusion","Critical Limb-Threatening Ischemia","Claudication, Intermittent",[89,90,91],"Extraluminal Bypass Stenting","Autologous Vein Graft","Bypass Extremity Graft","2023-11-20",{"date":94,"type":37},"2023-11-21",{"date":96,"type":37},"2023-09-11",{"date":98,"type":20},"2027-09",{"name":100,"class":70},"Paracelsus Medical University"]