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NCT07144150NARecruiting

EVERO Drug-coated Balloon (DCB) Randomized Trial

Cook Research Incorporated

Start Date

4/17/2026

Completion Date

10/1/2032

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

COMBINATION_PRODUCT

Evero DCB

COMBINATION_PRODUCT

Paclitaxel DCB

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Conditions

Peripheral Vascular DiseasePeripheral Arterial Disease

Locations

Yale New Haven Hospital

New Haven, Connecticut 06510

United States

The Cardiac and Vascular Institute

Gainesville, Florida 32605

United States

First Coast Cardiovascular Institute

Jacksonville, Florida 32256

United States

Baptist Cardiac and Vascular Institute

Miami, Florida 33176

United States

Midwest Cardiovascular Research Foundation

Davenport, Iowa 52801

United States

North Mississippi Medical Center

Tupelo, Mississippi 33801

United States

Prisma Health Memorial

Greenville, South Carolina 26905

United States