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EVERO Drug-coated Balloon (DCB) Randomized Trial
Sponsor: Cook Research Incorporated
Summary
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).
Official title: Advance Evero™ 18 Everolimus-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Versus Paclitaxel-coated Ballons in Patients With Femoropopliteal Disease (EVERO Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
410
Start Date
2026-04-17
Completion Date
2032-10
Last Updated
2026-07-02
Healthy Volunteers
No
Interventions
Evero DCB
PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
Paclitaxel DCB
PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
Locations (5)
The Cardiac and Vascular Institute
Gainesville, Florida, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
Prisma Health Memorial
Greenville, South Carolina, United States