[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100205550":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":23,"centralContacts":23,"locations":27,"responsibleParty":76,"collaborators":23,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":23,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":23,"enrollmentInfo":87,"targetDuration":23,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":23,"overallStatus":96,"whyStopped":23,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Flanders Medical Research Program","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Zilver PTX","EXPERIMENTAL","Patients in the Zilver PTX arm have to be treated by placement of the Zilver PTX drug-eluting stent (Cook), according to standard procedures based on the Instructions for Use. The only pre-treatment allowed prior to placement of the Zilver PTX drug-eluting stent (Cook) is standard PTA. Diameter measurements must be performed of the healthy vessel proximal and distal to the previously stented area. Diameter selection of the Zilver PTX drug-eluting stent (Cook) should result in minimal oversizing. The target lesion needs to be completely covered by using as few stents possible. Post-dilatation can be performed according to the Instructions of Use.",[13],"Device: Zilver PTX",{"label":15,"type":16,"description":17,"interventionNames":18},"prosthetic bypass","ACTIVE_COMPARATOR","Patients in the bypass arm have to be treated with a prosthetic bypass graft according to the institution's standard of care and the Instructions for Use of the prosthetic bypass graft.",[19],"Device: prosthetic bypass",[21,25],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":23},"DEVICE",null,[9],{"type":22,"name":15,"description":23,"armGroupLabels":26,"otherNames":23},[15],[28,40,49,58,67],{"facility":29,"status":23,"city":30,"state":23,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":23},"OLV Hospital","Aalst","9300","Belgium","BE",{"type":35,"coordinates":36},"Point",[37,38],4.0355,50.93604,{"lat":38,"lon":37},{"facility":41,"status":23,"city":42,"state":23,"zip":43,"country":32,"countryCode":33,"cosmosGeoPoint":44,"geoPoint":48,"contacts":23},"Imelda Hospital","Bonheiden","2820",{"type":35,"coordinates":45},[46,47],4.54714,51.02261,{"lat":47,"lon":46},{"facility":50,"status":23,"city":51,"state":23,"zip":52,"country":32,"countryCode":33,"cosmosGeoPoint":53,"geoPoint":57,"contacts":23},"AZ Sint-Blasius","Dendermonde","9200",{"type":35,"coordinates":54},[55,56],4.10106,51.02869,{"lat":56,"lon":55},{"facility":59,"status":23,"city":60,"state":23,"zip":61,"country":32,"countryCode":33,"cosmosGeoPoint":62,"geoPoint":66,"contacts":23},"University Hospital Antwerp","Edegem","2650",{"type":35,"coordinates":63},[64,65],4.44504,51.15662,{"lat":65,"lon":64},{"facility":68,"status":23,"city":69,"state":23,"zip":70,"country":32,"countryCode":33,"cosmosGeoPoint":71,"geoPoint":75,"contacts":23},"RZ Heilig Hart Hospital","Tienen","3300",{"type":35,"coordinates":72},[73,74],4.9378,50.80745,{"lat":74,"lon":73},{"type":77,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100205550","phase-4-the-cook-zilver-ptx-drug-eluting-stent-versus-bypass-surgery-for-the-treatment-the-cook-zilver-ptx-drug-eluting-stent-versus-bypass-surgery-of-femoropopliteal-tasc-cd-lesions-100205550",false,"NCT01952457","The Cook Zilver PTX Drug-eluting Stent Versus Bypass Surgery for the Treatment The Cook Zilver PTX Drug-eluting Stent Versus Bypass Surgery of Femoropopliteal TASC C&D Lesions","ZILVERPASS","Inclusion Criteria:\n\n* Patient presenting with lifestyle-limiting claudication, rest pain or minor tissue loss (Rutherford classification from 2 to 5)\n* Patient is willing to comply with specified follow-up evaluations at the specified times\n* Patient is \\>18 years old\n* Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study\n* Patient has a projected life-expectancy of at least 24 months\n* Noninvasive lower extremity arterial studies (resting or exercise) demonstrate ankle-brachial index ≤0.8\n* Patient is eligible for treatment with the Zilver PTX paclitaxel-eluting stent (Cook) or with surgical bypass placement\n* Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure\n* Stenotic or occlusive de novo lesion located in the femoropopliteal arteries, suitable for endovascular therapy and for bypass surgery\n* Total target lesion length is at least 15cm\n* Minimum of 1.0cm of healthy vessel (non-stenotic) both proximal and distal to the treatment area\n* P2 and P3 are patent and there is angiographic evidence of at least one vessel-runoff to the foot, that does not require intervention (\\\u003C50% stenotic)\n* Target vessel diameter visually estimated to be \\>4mm and \\\u003C9mm at the proximal and distal treatment segments within the SFA\n\nExclusion Criteria:\n\n* Untreated flow-limiting aortoiliac stenotic disease\n* Any previous surgery and\u002For endovascular procedure in the target vessel\n* Severe ipsilateral common\u002Fdeep femoral disease requiring surgical reintervention\n* Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment\n* Femoral or popliteal aneurysm located at the target vessel\n* Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)\n* No patent tibial arteries (\\>50% stenosis)\n* Prior ipsilateral femoral artery bypass\n* Severe medical comorbidities (untreated CAD\u002FCHF, severe COPD, metastatic malignancy, dementia, etc.) or other medical condition that would preclude compliance with the study protocol or 2-year life expectancy\n* Serum creatinine \\>2.5mg\u002FdL within 45 prior to study procedure unless the subject is currently on dialysis\n* Major distal amputation (above the transmetatarsal) in the study or non-study limb\n* Any previously known coagulation disorder, including hypercoagulability\n* Contraindication to anticoagulation or antiplatelet therapy\n* Known allergies to stent or bypass graft components (nickel-titanium, Dacron, ePTFE, etc.)\n* Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure\n* Currently participating in another clinical research trial\n* Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment\n* Any planned surgical intervention\u002Fprocedure within 30 days of the study procedure\n* Target lesion access in the Zilver PTX stent arm not performed by transfemoral approach","ALL","18 Years",{"count":88,"type":89},220,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","The objective of this clinical investigation is to evaluate the early and mid-term outcome (after 6 and 12 months) and the long-term (up to 24 months) outcome of the Zilver PTX paclitaxel-eluting stent (Cook) versus bypass surgery for the treatment of TASC C\\&D femoropopliteal lesions.",[95],"Peripheral Vascular Disease","UNKNOWN","2018-03-05",{"date":99,"type":100},"2018-03-06","ACTUAL",{"date":102,"type":23},"2014-08",{"date":104,"type":89},"2019-12",{"name":5,"class":6},5]