[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100419550":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":10,"locations":19,"responsibleParty":233,"collaborators":10,"id":235,"slug":236,"hasResults":237,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":237,"sex":242,"minAge":243,"maxAge":10,"enrollmentInfo":244,"targetDuration":247,"studyType":248,"phases":10,"briefSummary":249,"conditions":250,"keywords":10,"overallStatus":22,"whyStopped":10,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":265},{"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],[20,40,54,68,82,93,107,121,135,149,163,177,191,205,219],{"facility":21,"status":22,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Centre Hospitalier Universitaire Pellegrin","RECRUITING","Bordeaux","New Aquitaine","33000","France","FR",{"type":29,"coordinates":30},"Point",[31,32],-0.58046,44.84124,{"lat":32,"lon":31},[35],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Eric Ducasse, Pr","CONTACT","33609835704","eric.ducasse@chu-bordeaux.fr",{"facility":41,"status":22,"city":42,"state":10,"zip":43,"country":26,"countryCode":27,"cosmosGeoPoint":44,"geoPoint":48,"contacts":49},"Clinique Générale Annecy","Annecy","74000",{"type":29,"coordinates":45},[46,47],6.12565,45.90878,{"lat":47,"lon":46},[50],{"name":51,"role":37,"phone":52,"phoneExt":10,"email":53},"Laurence Destrieux, Dr","33662364432","laurence.destrieux@yahoo.com",{"facility":55,"status":22,"city":56,"state":10,"zip":57,"country":26,"countryCode":27,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Clinique Rhône Durance","Avignon","84000",{"type":29,"coordinates":59},[60,61],4.80892,43.94834,{"lat":61,"lon":60},[64],{"name":65,"role":37,"phone":66,"phoneExt":10,"email":67},"Jérôme Brunet, Dr.","33663809865","jeromebrunet2@wanadoo.fr",{"facility":69,"status":22,"city":70,"state":10,"zip":71,"country":26,"countryCode":27,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Centre hospitalier de la Côte Basque","Bayonne","64100",{"type":29,"coordinates":73},[74,75],-1.473,43.49316,{"lat":75,"lon":74},[78],{"name":79,"role":37,"phone":80,"phoneExt":10,"email":81},"Laurent Lagoarde, Dr","33611189298","mailto:llagoarde-segot@ch-cotebasque.fr",{"facility":83,"status":22,"city":23,"state":10,"zip":84,"country":26,"countryCode":27,"cosmosGeoPoint":85,"geoPoint":87,"contacts":88},"Polyclinic Bordeaux Nord Aquitaine","33300",{"type":29,"coordinates":86},[31,32],{"lat":32,"lon":31},[89],{"name":90,"role":37,"phone":91,"phoneExt":10,"email":92},"Dominique Biscay, Dr","33556437017","dr.biscay@gmail.com",{"facility":94,"status":22,"city":95,"state":10,"zip":96,"country":26,"countryCode":27,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Hôpital Ambroise Paré","Boulogne-Billancourt","92100",{"type":29,"coordinates":98},[99,100],2.24128,48.83545,{"lat":100,"lon":99},[103],{"name":104,"role":37,"phone":105,"phoneExt":10,"email":106},"Raphael Coscas, Pr","33149095585","raphael.coscas@aphp.fr",{"facility":108,"status":22,"city":109,"state":10,"zip":110,"country":26,"countryCode":27,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Centre Hospitalier Régional Universitaire Morvan de Brest","Brest","29200",{"type":29,"coordinates":112},[113,114],-4.48628,48.39029,{"lat":114,"lon":113},[117],{"name":118,"role":37,"phone":119,"phoneExt":10,"email":120},"Bahaa Nasr, Dr","33612116346","bahaa.nasr@chu-brest.fr",{"facility":122,"status":22,"city":123,"state":10,"zip":124,"country":26,"countryCode":27,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"CHRU Lille","Lille","59000",{"type":29,"coordinates":126},[127,128],3.05512,50.63391,{"lat":128,"lon":127},[131],{"name":132,"role":37,"phone":133,"phoneExt":10,"email":134},"Jonathan Sobocinski, Pr","33665902150","jonathan.sobocinski@chru-lille.fr",{"facility":136,"status":22,"city":137,"state":10,"zip":138,"country":26,"countryCode":27,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Clinic Mutualiste Porte de L'Orient","Lorient","56100",{"type":29,"coordinates":140},[141,142],-3.37177,47.74817,{"lat":142,"lon":141},[145],{"name":146,"role":37,"phone":147,"phoneExt":10,"email":148},"Jean Baptiste Bocquel, Dr","33688817794","jean-baptiste.bocquel@clinique.mutualite56.fr",{"facility":150,"status":22,"city":151,"state":10,"zip":152,"country":26,"countryCode":27,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"CHU Timone Marseille","Marseille","13005",{"type":29,"coordinates":154},[155,156],5.38107,43.29695,{"lat":156,"lon":155},[159],{"name":160,"role":37,"phone":161,"phoneExt":10,"email":162},"Michel Alain Bartoli, Pr","33491385762","michelalain.bartoli@ap-hm.fr",{"facility":164,"status":22,"city":165,"state":10,"zip":166,"country":26,"countryCode":27,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"CH Layné","Mont-de-Marsan","40024",{"type":29,"coordinates":168},[169,170],-0.49713,43.89022,{"lat":170,"lon":169},[173],{"name":174,"role":37,"phone":175,"phoneExt":10,"email":176},"Mathieu Poirier, Dr","33661901257","mathieu.poirier@ch-mdm.fr",{"facility":178,"status":22,"city":179,"state":10,"zip":180,"country":26,"countryCode":27,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Hôpital Privé des Franciscaines","Nîmes","30000",{"type":29,"coordinates":182},[183,184],4.35788,43.83665,{"lat":184,"lon":183},[187],{"name":188,"role":37,"phone":189,"phoneExt":10,"email":190},"Nicolas Louis, Dr","33671241324","drlouisnicolas@yahoo.fr",{"facility":192,"status":22,"city":193,"state":10,"zip":194,"country":26,"countryCode":27,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Fondation Hôpital St Joseph","Paris","75014",{"type":29,"coordinates":196},[197,198],2.3488,48.85341,{"lat":198,"lon":197},[201],{"name":202,"role":37,"phone":203,"phoneExt":10,"email":204},"Yann Goueffic, Pr","33625781753","ygoueffic@ghpsj.fr",{"facility":206,"status":22,"city":207,"state":10,"zip":208,"country":26,"countryCode":27,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Clinique Saint Jean","Saint-Jean-de-Védas","34430",{"type":29,"coordinates":210},[211,212],3.82603,43.57759,{"lat":212,"lon":211},[215],{"name":216,"role":37,"phone":217,"phoneExt":10,"email":218},"Benjamin Thévenin, Dr.","33789003025","thevenin.benjamin@hotmail.fr",{"facility":220,"status":22,"city":221,"state":10,"zip":222,"country":26,"countryCode":27,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Clinique Rhéna","Strasbourg","67000",{"type":29,"coordinates":224},[225,226],7.74553,48.58392,{"lat":226,"lon":225},[229],{"name":230,"role":37,"phone":231,"phoneExt":10,"email":232},"Gilles Goyault, Dr","33680330596","gillesgoyault@gmail.com",{"type":234,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100419550","european-all-comers-multicentric-prospective-registry-on-luminor-drug-eluting-balloon-in-the-superficial-femoral-artery-and-popliteal-artery-with-5-years-follow-up-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":245,"type":246},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.",[251,252,253,254,255],"Angioplasty","Peripheral Arterial Disease","Drug-eluting Balloon","Femoral Artery","Paclitaxel","2021-02-10",{"date":258,"type":259},"2021-02-11","ACTUAL",{"date":261,"type":259},"2021-01-18",{"date":263,"type":246},"2026-06-30",{"name":5,"class":6},15]