[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604025":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":41,"responsibleParty":93,"collaborators":25,"id":95,"slug":25,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":25,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":25,"enrollmentInfo":103,"targetDuration":25,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},{"fullName":5,"class":6},"Cook Group Incorporated","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Evero DCB","EXPERIMENTAL","Treatment with Evero drug-coated balloon to apply local treatment with everolimus",[13],"Combination Product: Evero DCB",{"label":15,"type":16,"description":17,"interventionNames":18},"Paclitaxel-coated DCB","ACTIVE_COMPARATOR","Treatment with commercially-available drug-coated balloons to apply local treatment with paclitaxel",[19],"Combination Product: Paclitaxel DCB",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries",[9],null,{"type":22,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"Paclitaxel DCB",[15],[30],{"name":31,"affiliation":32,"role":33},"Eric Secemsky, MD","Beth Israel Deaconess Medical Center","STUDY_CHAIR",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Noah Shields","CONTACT","765-463-7537","321174","noah.shields@cookmedical.com",[42,55,64,73,83],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":25},"The Cardiac and Vascular Institute","RECRUITING","Gainesville","Florida","32605","United States",{"type":50,"coordinates":51},"Point",[52,53],-82.32483,29.65163,{"lat":53,"lon":52},{"facility":56,"status":44,"city":57,"state":46,"zip":58,"country":48,"cosmosGeoPoint":59,"geoPoint":63,"contacts":25},"First Coast Cardiovascular Institute","Jacksonville","32256",{"type":50,"coordinates":60},[61,62],-81.65565,30.33218,{"lat":62,"lon":61},{"facility":65,"status":44,"city":66,"state":46,"zip":67,"country":48,"cosmosGeoPoint":68,"geoPoint":72,"contacts":25},"Baptist Cardiac and Vascular Institute","Miami","33176",{"type":50,"coordinates":69},[70,71],-80.19366,25.77427,{"lat":71,"lon":70},{"facility":74,"status":44,"city":75,"state":76,"zip":77,"country":48,"cosmosGeoPoint":78,"geoPoint":82,"contacts":25},"North Mississippi Medical Center","Tupelo","Mississippi","33801",{"type":50,"coordinates":79},[80,81],-88.70464,34.25807,{"lat":81,"lon":80},{"facility":84,"status":44,"city":85,"state":86,"zip":87,"country":48,"cosmosGeoPoint":88,"geoPoint":92,"contacts":25},"Prisma Health Memorial","Greenville","South Carolina","26905",{"type":50,"coordinates":89},[90,91],-82.39401,34.85262,{"lat":91,"lon":90},{"type":94,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100604025",false,"NCT07144150","EVERO Drug-coated Balloon (DCB) Randomized Trial","Advance Evero™ 18 Everolimus-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Versus Paclitaxel-coated Ballons in Patients With Femoropopliteal Disease (EVERO Trial)","Inclusion Criteria:\n\n1. Documented PAD with Rutherford classification 2 - 4; and\n2. De novo or restenotic (non-stented) target lesion located in the native superficial femoral artery (SFA), popliteal artery (P1 or P2), or both native SFA and popliteal arteries.\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria\n\n1. Less than 18 years old;\n2. Inability or refusal to give informed consent by the patient or legally authorized representative;\n3. Life expectancy ≤ 12 months, per investigator assessment;\n4. Pregnant (or if absence of pregnancy is not verified by negative pregnancy test within 7 days of planned procedure), lactating, planning to become pregnant within 12 months of the planned procedure, or unwilling to use contraception for 12 months following the planned procedure;\n5. Unable or unwilling to comply with the follow-up schedule; or\n6. Simultaneously participating in another investigational drug or device study unless the patient is at least 30 days beyond the primary endpoint of any previous study.","ALL","18 Years",{"count":104,"type":105},410,"ESTIMATED","INTERVENTIONAL",[108],"NA","The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Evero™ 18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter (hereafter referred to as the Evero drug-coated balloon \\[DCB\\]) in the treatment of the femoropopliteal artery lesions in patients with peripheral arterial disease (PAD). Specifically, the Randomized-Controlled Trial (RCT) is designed to demonstrate non-inferior safety and non-inferior effectiveness of the Evero DCB when compared to commercially available paclitaxel DCBs (pDCBs).",[111,112],"Peripheral Vascular Disease","Peripheral Arterial Disease",[114,115,116,117,118,119,120,121,122],"Intermittent claudication","Paclitaxel","Everolimus","Rapamycin","Drug-coated balloon (DCB)","Percutaneous transluminal angioplasty (PTA)","Femoropopliteal artery","Superficial femoral artery (SFA)","Popliteal artery","2026-07-01",{"date":125,"type":126},"2026-07-02","ACTUAL",{"date":128,"type":126},"2026-04-17",{"date":130,"type":105},"2032-10",{"name":132,"class":6},"Cook Research Incorporated",5]