EVERO Drug-coated Balloon (DCB) Randomized Trial
Recruiting now · Not applicable
Conditions studied: Peripheral Vascular Disease, Peripheral Arterial Disease
In brief
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).
Key facts
- Study ID
- NCT07144150
- Run by
- Cook Research Incorporated
- People needed
- 410
- Starts
- 2026-04-17
- Expected to finish
- 2032-10-01
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Documented PAD with Rutherford classification 2 - 4; and
- De novo or restenotic (non-stented) target lesion located in the native superficial femoral artery (SFA), popliteal artery (P1 or P2), or both native SFA and popliteal arteries.
You may not qualify if…
- General Exclusion Criteria
- Less than 18 years old;
- Inability or refusal to give informed consent by the patient or legally authorized representative;
- Life expectancy ≤ 12 months, per investigator assessment;
- Pregnant (or if absence of pregnancy is not verified by negative pregnancy test within 7 days of planned procedure), lactating, planning to become pregnant within 12 months of the planned procedure, or unwilling to use contraception for 12 months following the planned procedure;
- Unable or unwilling to comply with the follow-up schedule; or
- Simultaneously participating in another investigational drug or device study unless the patient is at least 30 days beyond the primary endpoint of any previous study.
Where it is running
- Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
- The Cardiac and Vascular Institute — Gainesville, Florida, United States (enrolling)
- First Coast Cardiovascular Institute — Jacksonville, Florida, United States (enrolling)
- Baptist Cardiac and Vascular Institute — Miami, Florida, United States (enrolling)
- Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States (enrolling)
- North Mississippi Medical Center — Tupelo, Mississippi, United States (enrolling)
- Prisma Health Memorial — Greenville, South Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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