N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Not applicable ClinicalTrials.gov

EVERO Drug-coated Balloon (DCB) Randomized Trial

Sponsor: Cook Research Incorporated • ClinicalTrials.gov ID: NCT07144150

Registry updated: 2026-10-13
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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).

Interventions

  • Evero DCB (Combination product)
    PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
  • Paclitaxel DCB (Combination product)
    PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries

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.

Conditions

Peripheral Vascular Disease Peripheral Arterial Disease

Locations

  • Long Beach Veterans Administration Hospital/SCIRE Research — Long Beach, California, United States
  • Yale New Haven Hospital — New Haven, Connecticut, United States
  • The Cardiac and Vascular Institute — Gainesville, Florida, United States
  • First Coast Cardiovascular Institute — Jacksonville, Florida, United States
  • Baptist Cardiac and Vascular Institute — Miami, Florida, United States
  • Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States
  • McLaren Bay Region Hospital — Bay City, Michigan, United States
  • North Mississippi Medical Center — Tupelo, Mississippi, United States
  • Cooper University Hospital — Camden, New Jersey, United States
  • Prisma Health Memorial — Greenville, South Carolina, United States
  • University of Texas Southwestern — Dallas, Texas, United States
  • Houston Methodist Hospital — Houston, Texas, United States
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record