[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604025":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":41,"responsibleParty":94,"collaborators":25,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":25,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":25,"enrollmentInfo":105,"targetDuration":25,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},{"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",[42,56,65,74,84],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":25},"The Cardiac and Vascular Institute","RECRUITING","Gainesville","Florida","32605","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-82.32483,29.65163,{"lat":54,"lon":53},{"facility":57,"status":44,"city":58,"state":46,"zip":59,"country":48,"countryCode":49,"cosmosGeoPoint":60,"geoPoint":64,"contacts":25},"First Coast Cardiovascular Institute","Jacksonville","32256",{"type":51,"coordinates":61},[62,63],-81.65565,30.33218,{"lat":63,"lon":62},{"facility":66,"status":44,"city":67,"state":46,"zip":68,"country":48,"countryCode":49,"cosmosGeoPoint":69,"geoPoint":73,"contacts":25},"Baptist Cardiac and Vascular Institute","Miami","33176",{"type":51,"coordinates":70},[71,72],-80.19366,25.77427,{"lat":72,"lon":71},{"facility":75,"status":44,"city":76,"state":77,"zip":78,"country":48,"countryCode":49,"cosmosGeoPoint":79,"geoPoint":83,"contacts":25},"North Mississippi Medical Center","Tupelo","Mississippi","33801",{"type":51,"coordinates":80},[81,82],-88.70464,34.25807,{"lat":82,"lon":81},{"facility":85,"status":44,"city":86,"state":87,"zip":88,"country":48,"countryCode":49,"cosmosGeoPoint":89,"geoPoint":93,"contacts":25},"Prisma Health Memorial","Greenville","South Carolina","26905",{"type":51,"coordinates":90},[91,92],-82.39401,34.85262,{"lat":92,"lon":91},{"type":95,"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":106,"type":107},410,"ESTIMATED","INTERVENTIONAL",[110],"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).",[113,114],"Peripheral Vascular Disease","Peripheral Arterial Disease",[116,117,118,119,120,121,122,123,124],"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":127,"type":128},"2026-07-02","ACTUAL",{"date":130,"type":128},"2026-04-17",{"date":132,"type":107},"2032-10",{"name":134,"class":6},"Cook Research Incorporated",5]