EVERO Drug-coated Balloon (DCB) Randomized Trial
NCT07144150 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 410
Last updated 2026-04-06
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).
Conditions
- Peripheral Vascular Disease
- Peripheral Arterial Disease
Interventions
- COMBINATION_PRODUCT
-
Evero DCB
PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
- COMBINATION_PRODUCT
-
Paclitaxel DCB
PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
Sponsors & Collaborators
-
Cook Research Incorporated
lead INDUSTRY
Principal Investigators
-
Eric Secemsky, MD · Beth Israel Deaconess Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2028-09-30
- Completion
- 2032-10-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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