EVERO Drug-coated Balloon (DCB) Randomized Trial
Advance Evero™ 18 Everolimus-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Versus Paclitaxel-coated Ballons in Patients With Femoropopliteal Disease (EVERO Trial)
- Peripheral Vascular Disease
- Peripheral Arterial Disease
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Cook Research Incorporated
- Enrolment target
- 410
- Started
- 17 April 2026
- Main results due
- September 2028
- Study sites
- 11
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: 1. Documented PAD with Rutherford classification 2 - 4; and 2. 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. Exclusion Criteria: General Exclusion Criteria 1. Less than 18 years old; 2. Inability or refusal to give informed consent by the patient or legally authorized representative; 3. Life expectancy ≤ 12 months, per investigator assessment; 4. 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; 5. Unable or unwilling to comply with the follow-up schedule; or 6. 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.
What this study is about
In the sponsor’s own words, from the registry.
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).
Study sites(11)
Yale New Haven Hospital
New Haven, Connecticut, United States
Recruiting
The Cardiac and Vascular Institute
Gainesville, Florida, United States
Recruiting
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Recruiting
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
Recruiting
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
Recruiting
McLaren Bay Region Hospital
Bay City, Michigan, United States
Recruiting
North Mississippi Medical Center
Tupelo, Mississippi, United States
Recruiting
Cooper University Hospital
Camden, New Jersey, United States
Recruiting
Prisma Health Memorial
Greenville, South Carolina, United States
Recruiting
University of Texas Southwestern
Dallas, Texas, United States
Recruiting
Houston Methodist Hospital
Houston, Texas, United States
Recruiting
Showing 11 of 11 sites. 11 of the 11 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07144150. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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