[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604025":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":41,"responsibleParty":124,"collaborators":25,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":25,"eligibilityCriteria":132,"healthyVolunteers":128,"sex":133,"minAge":134,"maxAge":25,"enrollmentInfo":135,"targetDuration":25,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":145,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},{"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",[42,56,66,75,84,94,104,114],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":25},"Yale New Haven Hospital","RECRUITING","New Haven","Connecticut","06510","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-72.92816,41.30815,{"lat":54,"lon":53},{"facility":57,"status":44,"city":58,"state":59,"zip":60,"country":48,"countryCode":49,"cosmosGeoPoint":61,"geoPoint":65,"contacts":25},"The Cardiac and Vascular Institute","Gainesville","Florida","32605",{"type":51,"coordinates":62},[63,64],-82.32483,29.65163,{"lat":64,"lon":63},{"facility":67,"status":44,"city":68,"state":59,"zip":69,"country":48,"countryCode":49,"cosmosGeoPoint":70,"geoPoint":74,"contacts":25},"First Coast Cardiovascular Institute","Jacksonville","32256",{"type":51,"coordinates":71},[72,73],-81.65565,30.33218,{"lat":73,"lon":72},{"facility":76,"status":44,"city":77,"state":59,"zip":78,"country":48,"countryCode":49,"cosmosGeoPoint":79,"geoPoint":83,"contacts":25},"Baptist Cardiac and Vascular Institute","Miami","33176",{"type":51,"coordinates":80},[81,82],-80.19366,25.77427,{"lat":82,"lon":81},{"facility":85,"status":44,"city":86,"state":87,"zip":88,"country":48,"countryCode":49,"cosmosGeoPoint":89,"geoPoint":93,"contacts":25},"Midwest Cardiovascular Research Foundation","Davenport","Iowa","52801",{"type":51,"coordinates":90},[91,92],-90.57764,41.52364,{"lat":92,"lon":91},{"facility":95,"status":44,"city":96,"state":97,"zip":98,"country":48,"countryCode":49,"cosmosGeoPoint":99,"geoPoint":103,"contacts":25},"North Mississippi Medical Center","Tupelo","Mississippi","33801",{"type":51,"coordinates":100},[101,102],-88.70464,34.25807,{"lat":102,"lon":101},{"facility":105,"status":44,"city":106,"state":107,"zip":108,"country":48,"countryCode":49,"cosmosGeoPoint":109,"geoPoint":113,"contacts":25},"Prisma Health Memorial","Greenville","South Carolina","26905",{"type":51,"coordinates":110},[111,112],-82.39401,34.85262,{"lat":112,"lon":111},{"facility":115,"status":44,"city":116,"state":117,"zip":118,"country":48,"countryCode":49,"cosmosGeoPoint":119,"geoPoint":123,"contacts":25},"Houston Methodist Hospital","Houston","Texas","77030",{"type":51,"coordinates":120},[121,122],-95.36327,29.76328,{"lat":122,"lon":121},{"type":125,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100604025","evero-drug-coated-balloon-dcb-randomized-trial-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":136,"type":137},410,"ESTIMATED","INTERVENTIONAL",[140],"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).",[143,144],"Peripheral Vascular Disease","Peripheral Arterial Disease",[146,147,148,149,150,151,152,153,154],"Intermittent claudication","Paclitaxel","Everolimus","Rapamycin","Drug-coated balloon (DCB)","Percutaneous transluminal angioplasty (PTA)","Femoropopliteal artery","Superficial femoral artery (SFA)","Popliteal artery","2026-08-11",{"date":157,"type":158},"2026-08-12","ACTUAL",{"date":160,"type":158},"2026-04-17",{"date":162,"type":137},"2032-10",{"name":164,"class":6},"Cook Research Incorporated",8]