Condition: End Stage Renal Disease (ESRD) · Kidney Failure · Chronic Renal Disease · Sponsor: W.L.Gore & Associates
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.
This description comes directly from the study's public registry record.
Bre Lester · 4806986670 · blester@wlgore.com
Manali Joglekar · 9288644063 · mjogleka@wlgore.com
Always discuss trial participation with your own doctor first.
| AKDHC Medical Research Services, LLC | Phoenix, Arizona, United States | Recruiting |
| Sarasota Memorial Hospital | Sarasota, Florida, United States | Recruiting |
| University of South Florida | Tampa, Florida, United States | Recruiting |
| Piedmont Augusta | Augusta, Georgia, United States | Recruiting |
| University of Louisville | Louisville, Kentucky, United States | Recruiting |
| University of Maryland | Baltimore, Maryland, United States | Recruiting |
| Brigham & Women's Hospital | Boston, Massachusetts, United States | Recruiting |
| Rutgers | Newark, New Jersey, United States | Recruiting |
| Mount Sinai Hospital | New York, New York, United States | Recruiting |
| Northwell Health | New York, New York, United States | Recruiting |
| Montefiore Medical Center | The Bronx, New York, United States | Recruiting |
| Surgical Specialists of Charlotte | Charlotte, North Carolina, United States | Recruiting |
+ 9 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04671771