[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"superficial-femoral-artery-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:superficial-femoral-artery-stenosis":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,80,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100618997","post-market-clinical-follow-up-of-smart-family-of-stents-in-treating-iliac-and-femoropopliteal-artery-disease-100618997",false,"NCT07338890","Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease","Post-Market Clinical Follow-Up Study of the S.M.A.R.T.™ Nitinol Stent System, S.M.A.R.T.™ CONTROL™ Nitinol Stent System and S.M.A.R.T. ™ Flex Vascular Stent System in the Treatment of Iliac and Femoropopliteal Artery Disease (REAL-SMART)","REAL-SMART","Inclusion Criteria: For data mining purposes, the following criteria will apply in determining which subjects to include in the study:\n\n* Subjects treated with SMART 120\u002F150, SMART CONTROL or SMART Flex according to the respective Instructions for Use for treatment in the iliac, superficial femoral and\u002For proximal popliteal arteries.\n* If an EC-approved informed consent waiver is not obtained, then documented informed consent from the subject or legal representative granting permission to share the subject's clinical data It is recommended to include subjects with follow-up data available for a minimum of five (5) years from the date of treatment\u002Fprocedure or until time of death, whichever came first.\n\nIt is recommended to include subjects with follow-up data available for a minimum of five (5) years from the date of treatment\u002Fprocedure or until time of death, whichever came first. Subjects not included because follow-up information is unavailable will be documented, wherever possible, with respect to demographics and presenting disease state to determine whether they are similar to subjects with follow-up that are enrolled.\n\nExclusion Criteria: For data mining purposes, the following criteria will apply in determining which subjects to exclude in the study:\n\n* Women who were pregnant or lactating at the time of the procedure.\n* Pediatric subjects (\\\u003C18 years of age) at the time of the procedure.","ALL","18 Years",{"count":20,"type":21},240,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to evaluate long-term safety and performance per the intended use of the S.M.A.R.T.™ Nitinol Stent System (SMART 120\u002F150), S.M.A.R.T.™ CONTROL™ Nitinol Stent System (SMART CONTROL) and S.M.A.R.T.™ Flex Vascular Stent System (SMART Flex) in the treatment of iliac and femoropopliteal artery disease.",[25,26,27],"Superficial Femoral Artery Stenosis","Iliac Artery Stenosis","Popliteal Artery Stenosis",[25,26,27,29,30,31,32,33],"SMART CONTROL Nitinol Stent System","SMART FLEX Vascular Stent System","SMART Nitinol Stent System","SFA Stenosis","PPA Stenosis","NOT_YET_RECRUITING","2026-01-04",{"date":37,"type":38},"2026-01-14","ACTUAL",{"date":40,"type":21},"2026-01-31",{"date":42,"type":21},"2026-05-30",{"name":44,"class":45},"Cordis US Corp.","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":46},"100395860","contribution-of-optical-coherence-tomography-in-the-endovascular-treatment-of-femoral-occlusions-100395860","NCT04434586","Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions","TOCAF","Inclusion Criteria:\n\n* Patient over 18 years old\n* Femoral-popliteal lesion TASC-C or TASC-D de novo (F1 to P1)\n* Starting lesion on the superficial femoral artery and not extending beyond the intercondylar notch (P2)\n* ≥1 continuous permeable leg axis directly injecting the plantar arch\n* Rutherford 2-5\n\nExclusion Criteria:\n\n* Patient under personal protection regime (tutorship, guardianship)\n* Absence of arterial axis in permeable leg\n* Patient presenting a limb acute ischaemia (chart evolving since less than 14 days)\n* Patient without favorable element to consider healing\n* History of stents on the femoropopliteal axis\n* History of femoropopliteal bypass\n* Untreated stenosis ≥30% on the iliac axis and common femoral upstream\n* Popliteal lesion beyond the intercondylar notch (P2)",{"count":55,"type":21},166,"INTERVENTIONAL",[58],"NA","This is a common care study. A study for evaluating the quality of balloon inflation and stent application will be performed in 2D angiography alone in the control group and then by 2D and OCT angiography for the experimental group. The benefit could be an improvement in the results of revascularization of femoropopliteal lesions thanks to OCT which allows a 3D visualization of the arterial lumen.",[25,61,62],"Claudication","Ischemic Leg",[64,65,66,67,68],"femoral recanalization","optical coherence tomography (OCT)","endovascular treatment","TASC-C,","TASC-D","RECRUITING","2025-12-16",{"date":72,"type":38},"2025-12-23",{"date":74,"type":38},"2020-06-16",{"date":76,"type":21},"2026-06",{"name":78,"class":79},"University Hospital, Lille","OTHER",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":56,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100547618","first-in-human-study-to-assess-safety-and-efficacy-of-the-championir-drug-eluting-peripheral-stent-in-the-treatment-of-patients-with-superficial-femoral-artery-disease-andor-proximal-popliteal-artery-disease-100547618","NCT06410313","First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and\u002For Proximal Popliteal Artery Disease","CHAMPIONSHIP","Inclusion Criteria:\n\n1. Age ≥ 18 years and of age of legal consent.\n2. Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index\u002Ftoe-brachial index (ABI\u002FTBI) \\\u003C0.90\u002F0.80.\n3. A single superficial femoral artery lesion with \\>50% stenosis or total occlusion.\n4. Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≤ 150 mm.\n5. Reference vessel diameter (RVD) ≥ 3.0 mm and ≤ 5.0 mm by visual assessment.\n6. Target lesion located with the distal point at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and proximal point at least 2 cm below the origin of the profunda femoris (deep femoral artery).\n7. Patent infra-popliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (\\\u003C50% stenosis) to the ankle or foot.\n8. The target lesion(s) can be successfully crossed with a guide wire and dilated.\n9. The subject is eligible for standard surgical repair, if necessary.\n10. Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent.\n\nExclusion Criteria:\n\n1. Presence of thrombus in the treated vessel as visualized by angiography, prior to crossing the lesion.\n2. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.\n3. Poor aortoiliac or common femoral \"inflow\" (i.e. angiographically defined \\>50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoro-popliteal bypass graft and was not successfully treated prior to treatment of the target lesion either within the same procedure or at least 30 days prior to the index procedure.\n4. Presence of residual ≥30% stenosis after either PTA or stenting of the inflow lesion.\n5. Presence of an ipsilateral arterial artificial graft.\n6. Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.\n7. Lesions in contralateral SFA\u002FPPA that require intervention during the index procedure, or within 30 days before or after the index procedure;\n8. Required stent placement (in the target or any other lesion) via a retrograde approach.\n9. Required stent placement (in the target or any other lesion) across or within 0.5 cm of the SFA \u002F PFA bifurcation.\n10. Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.\n11. Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.\n12. Required stent placement within 1 cm of a previously (in a former procedure) deployed stent.\n13. Use of atherectomy or other atheroablative (e.g. cryoplasty) devices at the time of index procedure.\n14. Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.\n15. Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.\n16. Overlapping stents are not allowed.\n17. Coronary intervention within 7 days prior to or planned within 30 days after the treatment of the target lesion.\n18. Stroke within the previous 30 days of the index procedure.\n19. Known allergies to any of the following: aspirin, P2Y12 inhibitors (clopidogrel bisulfate, prasugrel, OR ticagrelor), heparin OR bivalirudin, nitinol (nickel titanium), PDLG, PLC, PDL, limus drugs (ridaforolimus, zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue or derivative or similar compounds) or contrast agent, that cannot be medically managed.\n20. Receiving dialysis or immunosuppressant therapy within the previous 30 days.\n21. Known or suspected active systemic infection at the time of the procedure.\n22. Known bleeding or hypercoagulability disorder or significant anemia (Hb\\\u003C8.0) that cannot be corrected.\n23. Platelet count \\\u003C50,000\u002FμL\n24. International normalized ratio (INR) \\> 1.5\n25. GFR \\\u003C30 ml\u002Fmin by Cockroft-Gault.\n26. Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.\n27. Planned use of a drug coated balloon (DCB) during the index procedure.\n28. Pregnant women or women of childbearing potential who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment.\n29. Subject is participating in any investigational study that has not yet reached its primary endpoint","120 Years",{"count":89,"type":21},30,[58],"This is a prospective, open label, multicenter, single arm, first in human clinical study.\n\nPatients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be enrolled. The patients will be treated with the ChampioNIR Stent System. All implanted patients will be followed up at 30 days and 6, 12, 24 and 36 months. The follow-up visits will include patency evaluation by duplex ultrasound",[25,27],"2025-09-16",{"date":95,"type":38},"2025-09-22",{"date":97,"type":38},"2024-08-15",{"date":99,"type":21},"2030-02-28",{"name":101,"class":45},"Medinol Ltd.",7,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":56,"phases":112,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100572511","star-pak-study-evaluating-the-safety-and-efficacy-of-pak-paclitaxel-coated-balloon-in-treating-atherosclerotic-femoro-popliteal-lesions-100572511","NCT06734221","STAR-PAK Study: Evaluating the Safety and Efficacy of PAK® (Paclitaxel Coated Balloon) in Treating Atherosclerotic Femoro-Popliteal Lesions","STAR-PAK","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Written informed consent of the patient to participate in the study.\n3. Symptoms of lower limb ischemia defined by Rutherford classification from 2 to 4.\n4. At least one de novo or restenotic lesion, in SFA and\u002For PA defined as a lesion with a proximal origin \\>10mm from SFA origin and a distal end above the knee joint (at least 3 cm above bottom of the femur- P1).\n5. Target Lesion \\>60% stenosis in the SFA or PA (based on angio-CT and\u002For confirmed in angiography).\n6. Target Lesion \\\u003C150 mm that consists of no more than two adjacent lesions ≤ 25mm apart and is able to be completely covered with inflation of single investigated PAK DCB (with minimum of \\>5mm proximal and distal margin.\n\n   Note: Adjacent or tandem lesions must be treated as a single lesion.\n7. Reference Vessel Diameter (RVD) between 4.0 and 8.0mm and within treatment range of PAK® DCB to be used 1:1 at the target lesion.\n8. Angiographic evidence of distal run-off demonstrated by at least one patent tibial vessel without evidence of significant ≥50% angiographic stenosis from origin to ankle.\n9. In-flow vessel (both iliac and femoral) without significant ≥50% angiographic stenosis or successful treatment (≤30% residual stenosis with no complications) of a diseased in-flow vessel at least 30 days prior to the index procedure.\n\nNote: treatment of contralateral iliac arteries is allowed.\n\nExclusion Criteria:\n\n1. Life expectancy less than 2 years.\n2. Suspected or detected malignancy without completed treatment (not considered cured).\n3. Planned surgical or interventional procedures within 30 days after the study procedure.\n4. Known impaired renal function with GFR ≤30 mL\u002Fmin per 1.73 m2 and\u002For elevated serum creatinine \\> 2.5mg\u002FdL or on dialysis.\n5. Active inflammatory process at the site of the planned puncture.\n6. Acute lower limb ischemia.\n7. Non-atherosclerotic lesion (e.g. vasculitis, dysplasia).\n8. Necessary concurrent non-target lesion interventions involving a re-entry device, atherectomy, laser, or ablation procedures, the use of a drug eluting stent, or treatment with any other drug coated balloon.\n9. Massive calcifications of the treated lesion (defined as angiographic evidence of dense calcification present on both sides of the vessel wall on two orthogonal views and that extends \\>50 continuous mm in length; reflective 3 or 4 on the PACSS scale https:\u002F\u002Fdoi.org\u002F10.1002%2Fccd.25387).\n10. Angiographically confirmed presence of a thrombus in the target lesion.\n11. The target lesion requiring primary stenting.\n12. Presence of perforation, dissection (Type D or worse) or other injury in target vessel at time of enrollment.\n13. Previous bypass graft or stent at target vessel (must be greater than 20mm from target lesion), or iliac stent that cannot permit crossing by the treatment balloon within the introducer sheath Note: In-stent restenosis is not allowed.\n14. Gastrointestinal or any other major bleeding in the past three months.\n15. Known bleeding disorder or uncontrolled hypercoagulable disorder.\n16. Myocardial infarction or any stroke within 30 days prior to the procedure.\n17. Known intolerance to required medications (especially antiplatelets and heparin), contrast media (that cannot be adequately pre-medicated), nitinol or paclitaxel.\n18. Pregnant and childbearing age women not using effective contraception.\n19. Participation in another investigational study (before completing primary endpoint analysis) or previous enrollment to this study.",{"count":111,"type":21},120,[58],"The primary objective of the study is to evaluate the performance and the safety of the PAK® DCB Catheter in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and\u002For popliteal arteries (SFA\u002FPA) of patients with symptomatic peripheral artery disease (PAD).\n\nThe study enrolls patients who have been diagnosed with peripheral artery disease with stenosis of the superficial femoral or popliteal artery and are qualified for endovascular revascularization.\n\nLower extremity peripheral artery disease may be asymptomatic or may be accompanied by clinical symptoms due to restricted blood flow to the lower extremities.\n\nThe management of a patient diagnosed with peripheral arteriosclerosis is primarily aimed at reducing symptoms of limb ischemia and improving blood supply to the limb, as well as seeking to halt the progression of the disease.\n\nTreatment of lower extremity atherosclerosis with percutaneous methods is a well-known minimally invasive and recommended treatment for lower extremity ischemia.\n\nA maximum of 120 patients will be included in the study. All patients included in the study will receive treatment with the investigational device.\n\nThe study will use the PAK balloon catheter, which is CE certified and approved for the treatment of patients with peripheral vascular disease. That is, it is also used as standard outside the study. The test procedure with the study device is in accordance with its registration and instructions for use.",[115,116,25],"Popliteal Artery Stenosis Above the Knee","Peripheral Artery Disease",[116,118],"Drug Coated Balloon","2024-12-12",{"date":121,"type":38},"2024-12-16",{"date":123,"type":38},"2024-09-15",{"date":125,"type":21},"2026-09-15",{"name":127,"class":45},"Balton Sp.zo.o.",3]