A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease

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.

NCT Number	NCT04671771
Lead Sponsor	W.L.Gore & Associates
Conditions	End Stage Renal Disease (ESRD), Kidney Failure, Chronic Renal Disease, Hemodialysis
Enrollment	133 participants
Start Date	2020-12-03
Primary Completion	2027-12-01 (estimated)
Study Completion	2029-07-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-22