Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae (NCT03506308)
A Prospective, Global, Multicenter, Single Arm Post-Approval Study Investigating the Clinical Use and Safety of the Lutonix® Drug Coated Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae
🩺 Plain-English Summary (8th-Grade Level)
This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (26 Sites)
Showing the first 25 of 26 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- Flowers Hospital — Dothan, Alabama
- St. Joseph Hospital of Orange — Orange, California
- Kaiser Permanente — San Diego, California
- Yale University — New Haven, Connecticut
- University of Iowa Hospital and Clinics — Iowa City, Iowa
- University of Louisville — Louisville, Kentucky
- Ochsner Health System — New Orleans, Louisiana
- Ochsner Louisiana State University Health — Shreveport, Louisiana
- MedStar Health Research Institute — Annapolis, Maryland
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- University of Minnesota — Minneapolis, Minnesota
- Hackensack University Medical Center — Hackensack, New Jersey
- Columbia University Medical Center — New York, New York
- Rochester General Hospital — Rochester, New York
- Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania
- Dallas Vascular Center — Dallas, Texas
- HCA Houston Healthcare — Houston, Texas
- Houston Methodist Hospital — Houston, Texas
- University of Texas Health Science Center — Houston, Texas
- Sentara Medical Group — Norfolk, Virginia
- William Osler Health System/Brampton Civic Hospital — Brampton, Ontario
- Scarborough Health Network — Scarborough Village, Ontario
- University Health Network — Toronto, Ontario
💰 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 § 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 Arteriovenous Fistula
- IN.PACT™ AV Access Post-Approval Study (PAS002) — Los Angeles, California
Explore by condition: All Arteriovenous Fistula clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.