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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
2026-05
Completion Date
2032-10
Last Updated
2026-04-06
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 (1)
The Cardiac and Vascular Institute
Gainesville, Florida, United States