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

Testing a new graft for dialysis access in kidney disease patients.

Recruiting
18-90 years
All
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

The study is testing a new device called the InnAVasc Arteriovenous Graft (IG), which helps patients with end-stage renal disease (ESRD) receive hemodialysis (HD). Hemodialysis is a treatment that cleans the blood when kidneys stop working well. The graft is a tube that connects an artery to a vein, making it easier to access blood for dialysis. The study will check if the IG is safe and works well for 6 months.

People in the study will have the IG implanted in their arm and will visit the doctor for follow-ups for up to 2 years. They must be able to take certain medications like aspirin. Some people cannot join, like those with severe heart problems or certain infections.

  • The study requires follow-up visits over 2 years to monitor the graft.
  • Participants must be 18-90 years old and able to take antiplatelet medication.
  • Participants should not have severe heart disease or uncontrolled diabetes.
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Study details
    End Stage Renal Disease (ESRD)
    Kidney Failure
    Chronic Renal Disease
    Hemodialysis

NCT04671771

W.L.Gore & Associates

21 March 2026

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