[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100225384":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":20,"centralContacts":20,"locations":28,"responsibleParty":78,"collaborators":20,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":20,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":20,"enrollmentInfo":89,"targetDuration":20,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":20,"overallStatus":98,"whyStopped":20,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Flanders Medical Research Program","NETWORK",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Passeo-18-Lux & Pulsar-18","EXPERIMENTAL","The interventional procedure sequence consists of the following steps:\n\n1. pre-dilation of the lesion with a Passeo-18 balloon (mandatory)\n2. dilation of the lesion with a Passeo-18 Lux drug releasing balloon (mandatory); a maximum of 2 Passeo-18 Lux balloons can be used per lesion (drug load cannot exceed 12µg)\n3. stenting of the lesion with a Pulsar-18 stent (mandatory)\n4. post-dilation of the lesion with a Passeo-18 balloon (not mandatory)",[13,14,15],"Device: Passeo-18 balloon","Device: Passeo-18 Lux drug releasing balloon","Device: Pulsar-18 stent",[17,22,25],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":20},"DEVICE","Passeo-18 balloon",null,[9],{"type":18,"name":23,"description":20,"armGroupLabels":24,"otherNames":20},"Passeo-18 Lux drug releasing balloon",[9],{"type":18,"name":26,"description":20,"armGroupLabels":27,"otherNames":20},"Pulsar-18 stent",[9],[29,42,51,60,69],{"facility":30,"status":20,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":20},"University Hospital Antwerp","Edegem","Antwerp","2650","Belgium","BE",{"type":37,"coordinates":38},"Point",[39,40],4.44504,51.15662,{"lat":40,"lon":39},{"facility":43,"status":20,"city":44,"state":20,"zip":45,"country":34,"countryCode":35,"cosmosGeoPoint":46,"geoPoint":50,"contacts":20},"OLV Hospital","Aalst","9300",{"type":37,"coordinates":47},[48,49],4.0355,50.93604,{"lat":49,"lon":48},{"facility":52,"status":20,"city":53,"state":20,"zip":54,"country":34,"countryCode":35,"cosmosGeoPoint":55,"geoPoint":59,"contacts":20},"Imelda Hospital","Bonheiden","2820",{"type":37,"coordinates":56},[57,58],4.54714,51.02261,{"lat":58,"lon":57},{"facility":61,"status":20,"city":62,"state":20,"zip":63,"country":34,"countryCode":35,"cosmosGeoPoint":64,"geoPoint":68,"contacts":20},"AZ Sint-Blasius","Dendermonde","9200",{"type":37,"coordinates":65},[66,67],4.10106,51.02869,{"lat":67,"lon":66},{"facility":70,"status":20,"city":71,"state":20,"zip":72,"country":34,"countryCode":35,"cosmosGeoPoint":73,"geoPoint":77,"contacts":20},"RZ Heilig Hart Hospital","Tienen","3300",{"type":37,"coordinates":74},[75,76],4.9378,50.80745,{"lat":76,"lon":75},{"type":79,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100225384","phase-4-physician-initiated-trial-investigating-the-efficacy-of-endovascular-treatment-of-femoropopliteal-arterial-stenotic-disease-with-the-biotronik-passeo-18-lux-drug-releasing-balloon-and-the-biotronik-pulsar-18-stent-comparing-with-4ever-trial-results-100225384",false,"NCT02211664","Physician-Initiated Trial Investigating the Efficacy of Endovascular Treatment of Femoropopliteal Arterial Stenotic Disease With the Biotronik Passeo-18 Lux Drug Releasing Balloon and the Biotronik Pulsar-18 Stent (Comparing With 4EVER Trial Results)","BIOLUX 4EVER","Inclusion Criteria:\n\n1. General Inclusion Criteria:\n\n   * De novo lesions located in the femoropopliteal arteries suitable for endovascular treatment\n   * Patient presenting with a score from 2 to 4 according to the Rutherford classification\n   * Patient is willing to comply with specified follow-up evaluations at the predefined time intervals time\n   * Patients is \\>18 years old\n   * Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study\n   * Prior to enrollment, the target lesion was crossed with standard guidewire manipulation\n2. Angiographic Inclusion Criteria:\n\n   * The target lesions are located within the native SFA: distal point 3 cm above knee joint and 1 cm below the origin of the profunda femoralis\n   * The target lesion has angiographic evidence of stenosis \\>50% or occlusion\n   * Length of the target lesion is ≤ 19 cm by visual estimation and can be covered with one stent\n   * Target vessel diameter visually estimated is ≥4 mm and ≤6 mm\n   * There is angiographic evidence of at least one-vessel-runoff to the foot\n\nExclusion Criteria:\n\n* Presence of another stent in the target vessel that was placed during a previous procedure\n* Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis\n* Previous bypass surgery in the same limb\n* Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics\n* Patients who exhibit persistent acute intraluminal thrombus at the target lesion site\n* Perforation at the angioplasty site evidenced by extravasation of contrast medium\n* Patients with known hypersensitivity to nickel-titanium\n* Patients with uncorrected bleeding disorders\n* Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding\n* Life expectancy of less than 12 months\n* Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis \\> 30%\n* Use of thrombectomy, atherectomy or laser devices during procedure\n* Any planned surgical intervention\u002Fprocedure 30 days after the study procedure\n* Any patient considered to be hemodynamically unstable at onset of procedure\n* Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint","ALL","18 Years",{"count":90,"type":91},120,"ACTUAL","INTERVENTIONAL",[94],"PHASE4","The objective of this clinical investigation is to evaluate the short- and long-term (up to 24 months) outcome of treatment by means of dilation with the Passeo-18 Lux drug releasing balloon and by Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal arterial stenotic or occlusive lesions.",[97],"Peripheral Vascular Disease","COMPLETED","2018-08-10",{"date":101,"type":91},"2018-08-13",{"date":103,"type":91},"2014-06",{"date":105,"type":91},"2018-03",{"name":5,"class":6},5]