[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"femoral-artery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:femoral-artery":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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":19,"type":20},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.",[25,26,27,28,29],"Angioplasty","Peripheral Arterial Disease","Drug-eluting Balloon","Femoral Artery","Paclitaxel","RECRUITING","2021-02-10",{"date":33,"type":34},"2021-02-11","ACTUAL",{"date":36,"type":34},"2021-01-18",{"date":38,"type":20},"2026-06-30",{"name":40,"class":41},"iVascular S.L.U.","INDUSTRY",15]