A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease (NCT04671771)
🩺 Plain-English Summary (8th-Grade Level)
The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are: Primary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months. Primary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months. Participants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.
Who can join: Review the eligibility criteria below.
Location: AKDHC Medical Research Services, LLC — Phoenix, Arizona
Age range: 18 Years to 90 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 (21 Sites)
- AKDHC Medical Research Services, LLC — Phoenix, Arizona
- Sarasota Memorial Hospital — Sarasota, Florida
- University of South Florida — Tampa, Florida
- Piedmont Augusta — Augusta, Georgia
- University of Louisville — Louisville, Kentucky
- University of Maryland — Baltimore, Maryland
- Brigham & Women's Hospital — Boston, Massachusetts
- Rutgers — Newark, New Jersey
- Mount Sinai Hospital — New York, New York
- Northwell Health — New York, New York
- Montefiore Medical Center — The Bronx, New York
- Surgical Specialists of Charlotte — Charlotte, North Carolina
- Duke University Medical Center — Durham, North Carolina
- NC Heart and Vascular Research, LLC — Raleigh, North Carolina
- WakeMed — Raleigh, North Carolina
- Guthrie Clinic — Sayre, Pennsylvania
- Prisma Health- Upstate — Greenville, South Carolina
- Medical University of South Carolina — Orangeburg, South Carolina
- Baylor Heart and Vascular — Dallas, Texas
- Houston Methodist Hopsital — Houston, Texas
- University of Washington — Seattle, Washington
📞 Contact the Study Coordinator
Phone: (480) 698-6670
Email: blester@wlgore.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 End Stage Renal Disease (ESRD)
- Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure — Rochester, Minnesota
- Outcome of BCF Access in Hemodialysis Patients — Chicago, Illinois
- To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis — Scottsdale, Arizona
- Multi-Site STARgraft (10401) Trial — Brasília,
- Expanded Hemodialysis Versus High-Volume Online Hemodiafiltration for Uremic Toxin Removal — Mexico City, Mexico City
Explore by condition: All End Stage Renal Disease (ESRD) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.