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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

Examining the safety of InnAVasc graft for dialysis in kidney patients.

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

This study aims to check if a special tube, called the InnAVasc Arteriovenous Graft (IG), is safe and works well for people with end-stage renal disease (ESRD) who need hemodialysis (a process that cleans the blood). The graft helps create a good access point for hemodialysis.

**Hemodialysis (HD)** is a treatment for kidney failure that uses a machine to filter waste and water from your blood. **End-Stage Renal Disease (ESRD)** is when kidneys are no longer able to work as they should to meet your body's needs. **Arteriovenous Graft (AVG)** is a tube used to connect an artery to a vein, making it easier to get blood in and out for hemodialysis.

  • This study lasts for 2 years with follow-up visits required.
  • Participants need to be able to take certain medications like aspirin safely.
  • Participants must be between 18 and 90 years old and should not have certain health conditions.

Participants will have the graft implanted in their arm and need to attend regular check-ups. It's important to talk to your doctor about any risks or concerns before joining.

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Study details
    End Stage Renal Disease (ESRD)
    Kidney Failure
    Chronic Renal Disease
    Hemodialysis

NCT04671771

W.L.Gore & Associates

17 October 2026

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