InnAVasc Graft Implant for Kidney Failure
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must be able to continue or start antiplatelet therapy (medication to prevent blood clots) after the graft implant.
What data supports the effectiveness of the InnAVasc Graft Implant treatment for kidney failure?
The research suggests that arteriovenous grafts (AVGs) like the InnAVasc Graft are used in patients with kidney failure for hemodialysis access, and while they may have a higher initial catheter dependence compared to arteriovenous fistulas (AVFs), they offer a viable option for patients needing quick access. Additionally, early cannulation AVGs, such as the Acuseal, are noted for their advantages in early use, which may imply potential benefits for the InnAVasc Graft as well.12345
Is the InnAVasc Graft generally safe for humans?
How is the InnAVasc Graft treatment different from other treatments for kidney failure?
What is the purpose of this trial?
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.
Research Team
John Ross, MD
Principal Investigator
MUSC Health Dialysis Access Institute
Eligibility Criteria
This trial is for adults aged 18-90 with end-stage renal failure who need a new type of arteriovenous graft for hemodialysis. Candidates should have suitable anatomy for the implant, be able to start antiplatelet therapy, and not have severe cardiac issues, uncontrolled diabetes or hypertension, recent strokes, certain blood conditions, active infections or cancer treatments within the last year.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are surgically implanted with an InnAVasc Arteriovenous Graft (IG) for hemodialysis access
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of secondary patency and adverse events
Treatment Details
Interventions
- InnAVasc arteriovenous graft
InnAVasc arteriovenous graft is already approved in United States for the following indications:
- Hemodialysis access in patients with end-stage renal disease (ESRD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
InnAVasc Medical, Inc.
Lead Sponsor
W.L.Gore & Associates
Lead Sponsor
Bret Snyder
W.L.Gore & Associates
Chief Executive Officer since 2020
MBA from Stanford University
Dr. John Doe
W.L.Gore & Associates
Chief Medical Officer since 2023
MD from Harvard Medical School