Actively Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Led by Cook Research Incorporated · Updated on 2026-04-06
410
Participants Needed
1
Research Sites
335 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
EVERO Drug-coated Balloon (DCB) Randomized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented peripheral arterial disease with Rutherford classification 2 to 4
- Presence of a new or recurring (non-stented) lesion in the native superficial femoral artery, popliteal artery (P1 or P2), or both
- Adult aged 18 years or older
You will not qualify if you...
- Under 18 years old
- Unable or unwilling to give informed consent
- Life expectancy of 12 months or less as assessed by the investigator
- Pregnant, breastfeeding, planning pregnancy within 12 months, or unwilling to use contraception for 12 months after the procedure
- Unable or unwilling to comply with follow-up schedule
- Currently participating in another investigational drug or device study unless at least 30 days beyond the primary endpoint of that study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Cardiac and Vascular Institute
Gainesville, Florida, United States, 32605
Actively Recruiting
Research Team
N
Noah Shields
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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