[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100419550":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":10,"locations":19,"responsibleParty":232,"collaborators":10,"id":234,"slug":10,"hasResults":235,"nctId":236,"briefTitle":237,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":235,"sex":240,"minAge":241,"maxAge":10,"enrollmentInfo":242,"targetDuration":245,"studyType":246,"phases":10,"briefSummary":247,"conditions":248,"keywords":10,"overallStatus":22,"whyStopped":10,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},{"fullName":5,"class":6},"iVascular S.L.U.","INDUSTRY",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"LUMINOR© drug eluting balloon",null,[12],"Device: LUMINOR© Paclitaxel eluting balloon",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"DEVICE","LUMINOR© Paclitaxel eluting balloon","Patients will be treated with the Luminor paclitaxel eluting balloon",[9],[20,39,53,67,81,92,106,120,134,148,162,176,190,204,218],{"facility":21,"status":22,"city":23,"state":24,"zip":25,"country":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Centre Hospitalier Universitaire Pellegrin","RECRUITING","Bordeaux","New Aquitaine","33000","France",{"type":28,"coordinates":29},"Point",[30,31],-0.58046,44.84124,{"lat":31,"lon":30},[34],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Eric Ducasse, Pr","CONTACT","33609835704","eric.ducasse@chu-bordeaux.fr",{"facility":40,"status":22,"city":41,"state":10,"zip":42,"country":26,"cosmosGeoPoint":43,"geoPoint":47,"contacts":48},"Clinique Générale Annecy","Annecy","74000",{"type":28,"coordinates":44},[45,46],6.12565,45.90878,{"lat":46,"lon":45},[49],{"name":50,"role":36,"phone":51,"phoneExt":10,"email":52},"Laurence Destrieux, Dr","33662364432","laurence.destrieux@yahoo.com",{"facility":54,"status":22,"city":55,"state":10,"zip":56,"country":26,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Clinique Rhône Durance","Avignon","84000",{"type":28,"coordinates":58},[59,60],4.80892,43.94834,{"lat":60,"lon":59},[63],{"name":64,"role":36,"phone":65,"phoneExt":10,"email":66},"Jérôme Brunet, Dr.","33663809865","jeromebrunet2@wanadoo.fr",{"facility":68,"status":22,"city":69,"state":10,"zip":70,"country":26,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Centre hospitalier de la Côte Basque","Bayonne","64100",{"type":28,"coordinates":72},[73,74],-1.473,43.49316,{"lat":74,"lon":73},[77],{"name":78,"role":36,"phone":79,"phoneExt":10,"email":80},"Laurent Lagoarde, Dr","33611189298","mailto:llagoarde-segot@ch-cotebasque.fr",{"facility":82,"status":22,"city":23,"state":10,"zip":83,"country":26,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"Polyclinic Bordeaux Nord Aquitaine","33300",{"type":28,"coordinates":85},[30,31],{"lat":31,"lon":30},[88],{"name":89,"role":36,"phone":90,"phoneExt":10,"email":91},"Dominique Biscay, Dr","33556437017","dr.biscay@gmail.com",{"facility":93,"status":22,"city":94,"state":10,"zip":95,"country":26,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Hôpital Ambroise Paré","Boulogne-Billancourt","92100",{"type":28,"coordinates":97},[98,99],2.24128,48.83545,{"lat":99,"lon":98},[102],{"name":103,"role":36,"phone":104,"phoneExt":10,"email":105},"Raphael Coscas, Pr","33149095585","raphael.coscas@aphp.fr",{"facility":107,"status":22,"city":108,"state":10,"zip":109,"country":26,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Centre Hospitalier Régional Universitaire Morvan de Brest","Brest","29200",{"type":28,"coordinates":111},[112,113],-4.48628,48.39029,{"lat":113,"lon":112},[116],{"name":117,"role":36,"phone":118,"phoneExt":10,"email":119},"Bahaa Nasr, Dr","33612116346","bahaa.nasr@chu-brest.fr",{"facility":121,"status":22,"city":122,"state":10,"zip":123,"country":26,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"CHRU Lille","Lille","59000",{"type":28,"coordinates":125},[126,127],3.05512,50.63391,{"lat":127,"lon":126},[130],{"name":131,"role":36,"phone":132,"phoneExt":10,"email":133},"Jonathan Sobocinski, Pr","33665902150","jonathan.sobocinski@chru-lille.fr",{"facility":135,"status":22,"city":136,"state":10,"zip":137,"country":26,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Clinic Mutualiste Porte de L'Orient","Lorient","56100",{"type":28,"coordinates":139},[140,141],-3.37177,47.74817,{"lat":141,"lon":140},[144],{"name":145,"role":36,"phone":146,"phoneExt":10,"email":147},"Jean Baptiste Bocquel, Dr","33688817794","jean-baptiste.bocquel@clinique.mutualite56.fr",{"facility":149,"status":22,"city":150,"state":10,"zip":151,"country":26,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"CHU Timone Marseille","Marseille","13005",{"type":28,"coordinates":153},[154,155],5.38107,43.29695,{"lat":155,"lon":154},[158],{"name":159,"role":36,"phone":160,"phoneExt":10,"email":161},"Michel Alain Bartoli, Pr","33491385762","michelalain.bartoli@ap-hm.fr",{"facility":163,"status":22,"city":164,"state":10,"zip":165,"country":26,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"CH Layné","Mont-de-Marsan","40024",{"type":28,"coordinates":167},[168,169],-0.49713,43.89022,{"lat":169,"lon":168},[172],{"name":173,"role":36,"phone":174,"phoneExt":10,"email":175},"Mathieu Poirier, Dr","33661901257","mathieu.poirier@ch-mdm.fr",{"facility":177,"status":22,"city":178,"state":10,"zip":179,"country":26,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Hôpital Privé des Franciscaines","Nîmes","30000",{"type":28,"coordinates":181},[182,183],4.35788,43.83665,{"lat":183,"lon":182},[186],{"name":187,"role":36,"phone":188,"phoneExt":10,"email":189},"Nicolas Louis, Dr","33671241324","drlouisnicolas@yahoo.fr",{"facility":191,"status":22,"city":192,"state":10,"zip":193,"country":26,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Fondation Hôpital St Joseph","Paris","75014",{"type":28,"coordinates":195},[196,197],2.3488,48.85341,{"lat":197,"lon":196},[200],{"name":201,"role":36,"phone":202,"phoneExt":10,"email":203},"Yann Goueffic, Pr","33625781753","ygoueffic@ghpsj.fr",{"facility":205,"status":22,"city":206,"state":10,"zip":207,"country":26,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Clinique Saint Jean","Saint-Jean-de-Védas","34430",{"type":28,"coordinates":209},[210,211],3.82603,43.57759,{"lat":211,"lon":210},[214],{"name":215,"role":36,"phone":216,"phoneExt":10,"email":217},"Benjamin Thévenin, Dr.","33789003025","thevenin.benjamin@hotmail.fr",{"facility":219,"status":22,"city":220,"state":10,"zip":221,"country":26,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Clinique Rhéna","Strasbourg","67000",{"type":28,"coordinates":223},[224,225],7.74553,48.58392,{"lat":225,"lon":224},[228],{"name":229,"role":36,"phone":230,"phoneExt":10,"email":231},"Gilles Goyault, Dr","33680330596","gillesgoyault@gmail.com",{"type":233,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100419550",false,"NCT04743180","European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.","LUMIFOLLOW","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Rutherford Clinical Category 2-5\n* The subject is legally competent, has been informed of the nature, the scope, and the relevance of the study, voluntarily agrees to participation, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF)\n* Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery\n* TASC II Class A to D Lesions\n* de novo lesion(s), non-stented or stented restenotic lesion(s)\n* Proximal margin of target lesion(s) starts at the ostium of the superficial femoral artery, just below the common femoral bifurcation\n* Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk (P3)\n* A patent inflow artery free from significant lesion (≥ 50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of iliac or common femoral inflow artery lesions); Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without death or major vascular complication\n* Successful wire crossing and pre-dilatation (1min min, with under sizing of 1mm compared to ref diameter) of the target lesion; Use of crossing devices allowed if necessary. Use of laser or atherectomy is allowed if necessary, during the index procedure. Bailout stenting is allowed if necessary, after DEB use\n* At least one patent native outflow artery to the ankle, free from significant (≥ 50%) stenosis as confirmed by angiography (treatment of outflow disease is NOT permitted during the index procedure)\n\nExclusion Criteria:\n\n* Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children\n* Patient is contraindicated to use Luminor Drug Eluting Balloon per the current Instructions For Use (IFU)\n* Life expectancy of \\\u003C 1year\n* Patient is currently participating in an investigational drug or other device study or previously enrolled in this study\n* Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication\n* Sudden symptom onset, acute vessel occlusion, or acute or sub-acute angiographically visible thrombus in target vessel","ALL","18 Years",{"count":243,"type":244},500,"ESTIMATED","60 Months","OBSERVATIONAL","The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and\u002For long lesions\u002Focclusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.",[249,250,251,252,253],"Angioplasty","Peripheral Arterial Disease","Drug-eluting Balloon","Femoral Artery","Paclitaxel","2021-02-10",{"date":256,"type":257},"2021-02-11","ACTUAL",{"date":259,"type":257},"2021-01-18",{"date":261,"type":244},"2026-06-30",{"name":5,"class":6},15]