๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-21

Prevail Global Study (NCT06535854)

A Randomized Controlled Study of the Prevail Drug-Coated Balloon in Subjects With In-stent Restenosis and a Single Arm Prospectively Enrolled Study of the Prevail Drug-Coated Balloon for de Novo Lesions in Small Vessel Disease (Prevail Global).

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Medtronic Vascular

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.

Who can join: Review the eligibility criteria below.

Location: The University of Alabama at Birmingham โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

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

๐Ÿ“ All Participating Trial Locations (51 Sites)

Showing the first 25 of 51 sites.

  • The University of Alabama at Birmingham โ€” Birmingham, Alabama
  • Huntsville Hospital โ€” Huntsville, Alabama
  • Carondelet Saint Marys โ€” Tucson, Arizona
  • John L McClellan Memorial Veterans Hospital โ€” Little Rock, Arkansas
  • Stanford Hospital & Clinics โ€” Stanford, California
  • Medical Center of the Rockies โ€” Loveland, Colorado
  • Medstar Washington Hospital Center โ€” Washington D.C., District of Columbia
  • BayCare Health System โ€” Clearwater, Florida
  • North Florida Regional Medical Center โ€” Gainesville, Florida
  • University of Miami Hospital โ€” Miami, Florida
  • Emory University Hospital Midtown โ€” Atlanta, Georgia
  • Piedmont Atlanta Hospital โ€” Atlanta, Georgia
  • Advocate Illinois Masonic Medical Center โ€” Chicago, Illinois
  • Midwest Cardiovascular Institute โ€” Naperville, Illinois
  • Parkview Health โ€” Fort Wayne, Indiana
  • University of Kansas Medical Center โ€” Kansas City, Kansas
  • Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist) โ€” Overland Park, Kansas
  • Ascension Via Christi Saint Francis โ€” Wichita, Kansas
  • Saint Elizabeth Healthcare โ€” Edgewood, Kentucky
  • University of Michigan Health System - University Hospital โ€” Ann Arbor, Michigan
  • Corewell Health โ€” Grand Rapids, Michigan
  • Saint Joseph Mercy Ann Arbor โ€” Ypsilanti, Michigan
  • M Health Fairview Clinic โ€” Edina, Minnesota
  • CentraCare Heart & Vascular Center MN - Saint Cloud Hospital โ€” Saint Cloud, Minnesota
  • Saint Lukes Mid America Heart Institute โ€” Kansas City, Missouri

๐Ÿ“ž Contact the Study Coordinator

Phone: +31 (0)43.356.6566

Email: rs.prevailglobal@medtronic.com

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

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก 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.
๐Ÿ›๏ธ View Official NIH Record โ†—