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

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• End Stage Renal Disease (ESRD)
• Kidney Failure
• Chronic Renal Disease
• Hemodialysis

Eligibility basics and study details

Study type

Interventional

Phase

Not applicable

Ages

18 to 90 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

W.L.Gore & Associates

Last updated on ClinicalTrials.gov

October 8, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites