InnAVasc Arteriovenous Graft for Hemodialysis Access
This study is testing a new device called the InnAVasc Arteriovenous Graft (IG). This graft is a tube surgically placed in your arm to create a connection for hemodialysis (a treatment for kidney failure). The goal is to see how safe and effective the InnAVasc IG is for people with end-stage renal disease (ESRD), also known as kidney failure, who need hemodialysis. The study will look at how well the graft stays open and working for 6 months, and if there are any problems related to the device during that time. You may be able to join if you are between 18 and 90 years old and your doctor believes an AV graft is the best option for your hemodialysis access.
- Study design
- This study plans to enroll 133 participants. It is an interventional study, meaning participants will receive the InnAVasc Arteriovenous Graft surgical implant.
- What's involved
- Once enrolled, you will receive the study graft implant and participate in regular follow-up visits and assessments for up to 2 years after the implant.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 2 years after the graft implant.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
At a glance
Conditions
Where it's being run
21 sites across 13 statesStudy leadership
- John Ross, MD · PRINCIPAL_INVESTIGATOR · MUSC Health Dialysis Access Institute
Who to contact
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What this trial measures
- Secondary patency of study device at 6 months6 months
The primary effectiveness endpoint is defined as the proportion of subjects with secondary patency at 6 months.
- Incidence of adverse events of special interest related to InnAVasc AVG [Time Frame: through 6 months]6 months
The primary safety endpoint is the incidence of device-related adverse events of special interest (AESIs) through 6 months, defined as: 1. Infection of the study graft; 2. Pseudoaneurysm formation at any point along the study graft requiring surgical or endovascular intervention (pseudoaneurysms that occur at sites of needle cannulation, but which are small enough to be observed without intervention, do not trigger this element of the AESI endpoint); 3. Bleeding from the study graft requiring surgical or endovascular intervention or ≥2-unit blood transfusion; 4. Hematoma from the study graft requiring surgical or endovascular intervention; 5. Seroma of the study graft requiring surgical or endovascular intervention;