IN.PACT™ AV Access Post-Approval Study (PAS002) (NCT04543539)

🧪 Interventions in This Study

• IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort (COMBINATION_PRODUCT)
• IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort (COMBINATION_PRODUCT)

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (20 Sites)

• Cedars-Sinai Heart Institute — Los Angeles, California
• Stanford University Medical Center — Stanford, California
• Yale New Haven Hospital — New Haven, Connecticut
• Medstar Washington Hospital — Washington D.C., District of Columbia
• NCH Healthcare System — Naples, Florida
• Coastal Vascular and Interventional — Pensacola, Florida
• University of Iowa — Iowa City, Iowa
• University of Michigan Health System - University Hospital — Ann Arbor, Michigan
• Mayo Clinic — Rochester, Minnesota
• Holy Name Medical Center — Teaneck, New Jersey
• Albany Medical College — Albany, New York
• The Mount Sinai Hospital — New York, New York
• Staten Island University Hospital — Staten Island, New York
• FirstHealth of the Carolinas — Pinehurst, North Carolina
• Oregon Health & Science University Hospital — Portland, Oregon
• Lancaster General Hospital — Lancaster, Pennsylvania
• MUSC Health Dialysis Access Institute — Orangeburg, South Carolina
• Spartanburg Regional Medical Center — Spartanburg, South Carolina
• University of Virginia Medical Center — Charlottesville, Virginia
• University of Wisconsin-Madison - Meriter Hospital — Madison, Wisconsin

💰 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

• Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae — Birmingham, Alabama

Explore by condition: All Arteriovenous Fistula clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
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.