A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
W.L.Gore & Associates
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. 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.
Description
The InnAVasc Arteriovenous Graft (IG) is intended for use in ESRD hemodialysis (HD) patients who require HD and whose next most appropriate access is an arteriovenous graft (AVG), also including those who may require an immediate cannulation AVG. Patients with ESRD who require HD and are suitable for an AVG for HD access will be eligible for inclusion in the study. Subjects will be implanted with an InnAVasc Arteriovenous Graft (IG) in the forearm or upper arm using standard vascular surgical techniques. The graft will be placed in a "straight" (soft "C") configuration in the upper arm, or lo…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Pre-Operative Inclusion Criteria: Patients must meet the following criteria at screening in order to be scheduled for a procedure and potentially enrolled in the study: 1. Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy; 2. Age 18 to 90 years old, inclusive; 3. Suitable anatomy for implantation of upper arm "straight" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow); 4. Ability to continue or commence antiplatelet therapy post graft implant (antico…
Interventions
- DeviceInnAVasc Arteriovenous Graft (IG) surgical implant
The InnAVasc Arteriovenous Graft (IG) is a hemodialysis vascular access graft, intended for implantation in the lower or upper arm using standard vascular techniques, in patients requiring hemodialysis
Locations (21)
- AKDHC Medical Research Services, LLCPhoenix, Arizona
- Sarasota Memorial HospitalSarasota, Florida
- University of South FloridaTampa, Florida
- Piedmont AugustaAugusta, Georgia
- University of LouisvilleLouisville, Kentucky
- University of MarylandBaltimore, Maryland