πŸ›οΈ Verified NIH Record β€’ Updated 2026-08-11

EVERO Drug-coated Balloon (DCB) Randomized Trial (NCT07144150)

Advance Everoβ„’ 18 Everolimus-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Versus Paclitaxel-coated Ballons in Patients With Femoropopliteal Disease (EVERO Trial)

🟒 Recruiting Observational / Diagnostic πŸ’Š Investigational Drug / Biologic Sponsor: Cook Research Incorporated

🩺 Plain-English Summary (8th-Grade Level)

The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Everoβ„’ 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).

Who can join: Review the eligibility criteria below.

Location: Yale New Haven Hospital β€” New Haven, Connecticut

Age range: 18 Years

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (8 Sites)

  • Yale New Haven Hospital β€” New Haven, Connecticut
  • The Cardiac and Vascular Institute β€” Gainesville, Florida
  • First Coast Cardiovascular Institute β€” Jacksonville, Florida
  • Baptist Cardiac and Vascular Institute β€” Miami, Florida
  • Midwest Cardiovascular Research Foundation β€” Davenport, Iowa
  • North Mississippi Medical Center β€” Tupelo, Mississippi
  • Prisma Health Memorial β€” Greenville, South Carolina
  • Houston Methodist Hospital β€” Houston, Texas

πŸ“ž Contact the Study Coordinator

Phone: (765) 463-7537

Email: noah.shields@cookmedical.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Peripheral Vascular Disease

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—