๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-01

Serranator POINT FORCE Registry (NCT06687590)

POst-Market ClINical Follow-up STudy oF the SerranatOR PTA Serration Balloon CathEter

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Cagent Vascular LLC

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

The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranatorยฎ in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario. The data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.

Who can join: Review the eligibility criteria below.

Location: HonorHealth โ€” Scottsdale, Arizona

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 (19 Sites)

  • HonorHealth โ€” Scottsdale, Arizona
  • Cedars-Sinai Medical Center โ€” Los Angeles, California
  • Hartford HealthCare โ€” Hartford, Connecticut
  • MedStar Washington Hospital / MedStar Montgomery โ€” Washington D.C., District of Columbia
  • Manatee Memorial โ€” Bradenton, Florida
  • Radiology and Imaging Specialists โ€” Lakeland, Florida
  • Henry Ford Health โ€” Detroit, Michigan
  • Barnes Jewish โ€” St Louis, Missouri
  • Atlantic Medical Imaging โ€” Brick, New Jersey
  • Virtua Health โ€” Marlton, New Jersey
  • Northwell โ€” New Hyde Park, New York
  • Ohio State University Medical Center โ€” Columbus, Ohio
  • Miami Valley Hospital โ€” Dayton, Ohio
  • Oregon Health & Sciences University โ€” Portland, Oregon
  • Penn Presbyterian Medical Center โ€” Philadelphia, Pennsylvania
  • Jefferson Einstein โ€” Philadelphia, Pennsylvania
  • Brown Health โ€” Providence, Rhode Island
  • Prisma Health โ€” Greenville, South Carolina
  • Aurora St. Luke's โ€” Milwaukee, Wisconsin

๐Ÿ“ž Contact the Study Coordinator

Phone: (650) 208-6743

Email: ashewfelt33@cagentvascular.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†—