EVERO Drug-coated Balloon (DCB) Randomized Trial

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).

NCT Number	NCT07144150
Lead Sponsor	Cook Research Incorporated
Conditions	Peripheral Vascular Disease, Peripheral Arterial Disease
Enrollment	410 participants
Start Date	2026-04-17
Primary Completion	2028-09 (estimated)
Study Completion	2032-10 (estimated)
Updated on ClinicalTrials.gov	2026-08-12