EVERO Drug-coated Balloon (DCB) Randomized Trial
Start Date
4/17/2026
Completion Date
10/1/2032
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Evero DCB
Paclitaxel DCB
Conditions
Locations
Yale New Haven Hospital
New Haven, Connecticut 06510
United States
The Cardiac and Vascular Institute
Gainesville, Florida 32605
United States
First Coast Cardiovascular Institute
Jacksonville, Florida 32256
United States
Baptist Cardiac and Vascular Institute
Miami, Florida 33176
United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa 52801
United States
North Mississippi Medical Center
Tupelo, Mississippi 33801
United States
Prisma Health Memorial
Greenville, South Carolina 26905
United States