[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100353620":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":25,"locations":34,"responsibleParty":177,"collaborators":179,"id":183,"slug":184,"hasResults":185,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":185,"sex":191,"minAge":192,"maxAge":25,"enrollmentInfo":193,"targetDuration":25,"studyType":196,"phases":197,"briefSummary":199,"conditions":200,"keywords":25,"overallStatus":202,"whyStopped":25,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":211,"locationsCount":212},{"fullName":5,"class":6},"KANDO Research","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Passeo-18 Lux treatment group","EXPERIMENTAL","These patients will be treated with the Passeo-18 Lux (Biotronik).",[13],"Device: Passeo-18 Lux treatment group",{"label":15,"type":16,"description":17,"interventionNames":18},"IN.PACT Admiral treatment group","ACTIVE_COMPARATOR","These patients will be treated with the IN.PACT Admiral (Medtronic).",[19],"Device: IN.PACT Admiral treatment group",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Percutaneous endovascular angioplasty with the Passeo-18 lux",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Percutaneous endovascular angioplasty with the IN.PACT Admiral",[15],[30],{"name":31,"affiliation":32,"role":33},"Koen Deloose, MD","AZ Sint-Blasius","PRINCIPAL_INVESTIGATOR",[35,47,57,68,78,87,96,105,114,126,136,146,155,167],{"facility":36,"status":25,"city":37,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":25},"Medical University of Graz","Graz","8036","Austria","AT",{"type":42,"coordinates":43},"Point",[44,45],15.44197,47.06733,{"lat":45,"lon":44},{"facility":48,"status":25,"city":49,"state":50,"zip":51,"country":39,"countryCode":40,"cosmosGeoPoint":52,"geoPoint":56,"contacts":25},"Hanusch Hospital","Vienna","State of Vienna","1140",{"type":42,"coordinates":53},[54,55],16.37208,48.20849,{"lat":55,"lon":54},{"facility":58,"status":25,"city":59,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":67,"contacts":25},"UZA","Antwerp","2650","Belgium","BE",{"type":42,"coordinates":64},[65,66],4.40026,51.22047,{"lat":66,"lon":65},{"facility":69,"status":25,"city":70,"state":71,"zip":72,"country":61,"countryCode":62,"cosmosGeoPoint":73,"geoPoint":77,"contacts":25},"OLV Ziekenhuis Aalst","Aalst","Oost-Vlaanderen","9300",{"type":42,"coordinates":74},[75,76],4.0355,50.93604,{"lat":76,"lon":75},{"facility":79,"status":25,"city":80,"state":25,"zip":81,"country":61,"countryCode":62,"cosmosGeoPoint":82,"geoPoint":86,"contacts":25},"Imelda Hospital","Bonheiden","2820",{"type":42,"coordinates":83},[84,85],4.54714,51.02261,{"lat":85,"lon":84},{"facility":88,"status":25,"city":89,"state":25,"zip":90,"country":61,"countryCode":62,"cosmosGeoPoint":91,"geoPoint":95,"contacts":25},"A.Z. Sint-Blasius","Dendermonde","9200",{"type":42,"coordinates":92},[93,94],4.10106,51.02869,{"lat":94,"lon":93},{"facility":97,"status":25,"city":98,"state":25,"zip":99,"country":61,"countryCode":62,"cosmosGeoPoint":100,"geoPoint":104,"contacts":25},"Z.O.L.","Genk","3600",{"type":42,"coordinates":101},[102,103],5.50082,50.965,{"lat":103,"lon":102},{"facility":106,"status":25,"city":107,"state":25,"zip":108,"country":61,"countryCode":62,"cosmosGeoPoint":109,"geoPoint":113,"contacts":25},"R.Z. Heilig Hart","Tienen","3300",{"type":42,"coordinates":110},[111,112],4.9378,50.80745,{"lat":112,"lon":111},{"facility":115,"status":25,"city":116,"state":117,"zip":118,"country":119,"countryCode":120,"cosmosGeoPoint":121,"geoPoint":125,"contacts":25},"CHU Bordeaux","Bordeaux","New Aquitaine","33300","France","FR",{"type":42,"coordinates":122},[123,124],-0.58046,44.84124,{"lat":124,"lon":123},{"facility":127,"status":25,"city":128,"state":129,"zip":130,"country":119,"countryCode":120,"cosmosGeoPoint":131,"geoPoint":135,"contacts":25},"Clinique Pasteur","Toulouse","Occitanie","3100",{"type":42,"coordinates":132},[133,134],1.44367,43.60426,{"lat":134,"lon":133},{"facility":137,"status":25,"city":138,"state":139,"zip":140,"country":119,"countryCode":120,"cosmosGeoPoint":141,"geoPoint":145,"contacts":25},"Clinique Rhône Durance","Avignon","Provence-Alpes-Côte d'Azur Region","84000",{"type":42,"coordinates":142},[143,144],4.80892,43.94834,{"lat":144,"lon":143},{"facility":147,"status":25,"city":148,"state":25,"zip":149,"country":119,"countryCode":120,"cosmosGeoPoint":150,"geoPoint":154,"contacts":25},"Hopital Paris Saint Joseph","Paris","75014",{"type":42,"coordinates":151},[152,153],2.3488,48.85341,{"lat":153,"lon":152},{"facility":156,"status":25,"city":157,"state":158,"zip":159,"country":160,"countryCode":161,"cosmosGeoPoint":162,"geoPoint":166,"contacts":25},"Centre Hospitalier Universitaire Vaudois","Lausanne","Canton of Vaud","CH-1011","Switzerland","CH",{"type":42,"coordinates":163},[164,165],6.63282,46.516,{"lat":165,"lon":164},{"facility":168,"status":25,"city":169,"state":170,"zip":171,"country":160,"countryCode":161,"cosmosGeoPoint":172,"geoPoint":176,"contacts":25},"Triemlispital Zürich","Zurich","Canton of Zurich","8063",{"type":42,"coordinates":173},[174,175],8.55,47.36667,{"lat":175,"lon":174},{"type":178,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[180],{"name":181,"class":182},"Xper research","UNKNOWN","100353620","a-trial-to-evaluate-the-safety-and-efficacy-of-the-passeo-18-lux-drug-coated-balloon-of-biotronik-in-the-treatment-of-the-femoropopliteal-artery-compared-to-the-medtronic-inpact-admiral-drug-coated-balloon-100353620",false,"NCT03884257","A Trial to Evaluate the Safety and Efficacy of the Passeo-18 Lux Drug-coated Balloon of Biotronik in the Treatment of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral Drug-coated Balloon.","A Randomized Controlled Non-inferiority Trial to Evaluate the Safety and Efficacy of the Passeo-18 Lux Drug-coated Balloon of Biotronik in the Treatment of Subjects With Stenotic, Restenotic or Occlusive Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral Drug-coated Balloon","BIOPACT-RCT","Inclusion Criteria:\n\n* Subject is ≥18 years\n* Subject has Rutherford classification 2, 3 or 4\n* Subject has provided written informed consent and is willing to comply with study follow- up requirements\n* De novo stenotic or occlusive lesion(s) or non-stented restenotic or occlusive lesion(s) occurring \\>90 days after prior plain old balloon (POBA) angioplasty or \\>180 days after prior DCB treatment\n* Target lesion is located between the ostium of the SFA and the end of the P1 segment of the popliteal artery\n* Target vessel diameter ≥4mm and ≤7mm\n* Target lesion must be stenotic lesion ≤180mm in length (one long lesion or tandem lesions) by investigator's visual estimate or a total occlusion ≤120mm in length by investigator's visual estimate.\n\nNote: tandem lesions must have a total length of ≤180mm by visual estimate and be separated by ≤30mm\n\n* Target lesion must have angiographic evidence of ≥70% stenosis by investigator's visual estimation\n* Successful, uncomplicated crossing of the target lesion occurs when the tip of the guide wire is distal to the target lesion without the occurrence of flow-limiting dissection or perforation and is judged by visual inspection to be within the true lumen. Subintimal dissection techniques may be used if re-entry occurs above the knee (ATK) and without the use of re-entry devices\n* Target lesion is located at least 30mm from any stent, if target vessel was previously stented\n* After pre-dilatation, the target lesion is ≤50% residual stenosis, absence of a flow-limiting dissection and treatable with available device matrix\n* A patent inflow artery free from significant stenosis (≥50% stenosis) as confirmed by angiography\n* At least one patent native outflow artery to the ankle or foot, free from significant stenosis (≥50% stenosis) as confirmed by angiography\n\nExclusion Criteria:\n\n* Acute limb ischemia\n* Patient underwent an intervention involving the target vessel within the previous 90 days\n* Patient underwent any lower extremity percutaneous treatment in the ipsilateral limb using a paclitaxel-eluting stent or DCB within the previous 90 days\n* Patient underwent a percutaneous transluminal angioplasty (PTA) of the target lesion using a DCB within the previous 180 days\n* Women who are pregnant, breast-feeding or intend to become pregnant\n* Patient has life expectancy of less than 1 year\n* Patient has a known allergy to contrast medium that cannot be adequately pre-medicated\n* Patient is allergic to all antiplatelet treatments\n* Patient is receiving immunosuppressant therapy\n* Patient has platelet count \\\u003C100.000\u002Fmm3 or \\>700.000\u002Fmm3\n* Patient has history of gastrointestinal haemorrhage requiring a transfusion within 3 months prior to the study procedure\n* Patient is diagnosed with coagulopathy that precludes treatment with systemic anticoagulation and\u002For dual antiplatelet therapy (DAPT)\n* Patient has history of stroke within the past 90 days\n* Patient has history of myocardial infarction within the past 30 days\n* Patient is participating in an investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study, or patient is planning to participate in such study prior to the completion of this study\n* Patient has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days prior to the index procedure or has planned major surgical procedure or intervention within 30 days of the index procedure\n* An intervention in the contralateral limb, planned within 30 days post-index procedure\n* Patient had previous bypass surgery of the target lesion\n* Patient had previous treatment of the target vessel with thrombolysis or surgery\n* Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol\n* Target lesion involves an aneurysm or is adjacent to an aneurysm (within 5mm)\n* Target lesion requires treatment with alternative therapy such as stenting, laser, atherectomy, cryoplasty, brachytherapy or re-entry devices\n* Significant target vessel tortuosity or other parameters prohibiting access to the target lesion\n* Presence of thrombus in the target vessel\n* Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤30% residual diameter stenosis without death or major complications\n* Presence of an aortic, iliac or femoral artificial graft","ALL","18 Years",{"count":194,"type":195},302,"ACTUAL","INTERVENTIONAL",[198],"NA","The BIOPACT RCT tiral investigates the efficacy and safety of stenosis, restenosis or occlusions in the femoropopliteal artery of patients presenting a rutherford classification 2,3 or 4 with a Passeo-18 Lux drug-coated balloon of Biotronik. The Paclitaxel eluting balloons are designed for percutaneous transluminal angioplasties in which the balloon will dilate the artery upon inflation and deliver the paclitaxel locally.\n\nAn expected total of 151 patients will be treated with the Passeo-18 Lux and compared to a control group of another 151 patients that will be treated with the IN.PACT Admiral drug-coated balloon of Medtronic. Assignment to the treatment groups will be at random. The study will be conducted in two phases. A first pilot study phase of 120 patients distributed evenly over both treatment groups and a second phase to formally test the non-inferiority hypothesis.\n\nThe balloon is coated with Paclitaxel intended to avoid cellular proliferation. The drug is released by means of rapid inflation as to release a high dose in a short amount of time. Patients will be invited for a follow-up visit at 1, 6 and 12 months post-procedure.\n\nThe primary efficacy endpoints are defined as follows. Freedom from clinically-driven target lesion revascularization at 12 months. Freedom from device- and procedure-related death through 30 days post-index procedure, major target limb amputation through 12 months post-procedure and clinically-driven target vessel revascularization through 12 months post-index procedure. The secondary endpoints are defined as acute device success, acute procedural success , freedom from all cause of death, major target limb amputation and clinically driven target vessel revascularisation through 30 days post-procedure, sustained clinical improvement, no major adverse events through 6 and 12 months post-procedure, primary patency, target lesion revascularisation, target vessel revascularisation, binary restenosis, major target limb amputation, thrombosis at target lesion, change of walking impairment questionnaire score from baseline, change in target limb rutherford classification or ABI.",[201],"Peripheral Arterial Disease","ACTIVE_NOT_RECRUITING","2026-06-08",{"date":205,"type":195},"2026-06-10",{"date":207,"type":195},"2020-02-18",{"date":209,"type":210},"2026-10-06","ESTIMATED",{"name":5,"class":6},14]