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Arteriovenous Graft

InnAVasc Graft Implant for Kidney Failure

N/A

Recruiting

Led By John Ross, MD

Research Sponsored by InnAVasc Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Suitable anatomy for implantation of upper arm 'straight' or looped graft, or forearm looped graft (graft not to cross the bend of the elbow)

Age 18 to 90 years old, inclusive

Must not have

Known or suspected central vein stenosis or obstruction on the side of planned graft implantation

For upper arm straight configuration, antecubital fossa crease to axillary crease distance < 18 cm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 12, 18 and 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether the InnAVasc AVG is safe and works better than other standard-of-care dialysis grafts.

Who is the study for?

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.

What is being tested?

The study tests the InnAVasc arteriovenous graft designed for immediate use in hemodialysis patients. It aims to reduce bleeding post-dialysis and protect against needle misplacement compared to standard dialysis grafts.

What are the potential side effects?

Potential side effects may include complications at the implant site such as infection or clotting, bleeding during or after dialysis sessions due to immediate access use, and reactions related to antiplatelet therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My arm's structure allows for a specific type of graft without crossing the elbow.

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I am between 18 and 90 years old.

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I have end-stage renal disease and need an AV graft for dialysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I might have a blocked or narrowed vein where my graft is planned.

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The distance from my elbow crease to my armpit is less than 18 cm.

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I cannot or do not want to complete all required follow-ups and questionnaires.

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I have HIV/AIDS or am on immunosuppressive therapy for an acute event, but chronic therapy is okay.

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I have a bleeding condition not related to end-stage renal disease.

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I am scheduled for a kidney transplant within the next 6 months.

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I do not have severe artery problems in the limb chosen for the implant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 12, 18 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 12, 18 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12, 18 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events of special interest related to InnAVasc AVG [Time Frame: through 6 months]

Secondary patency of study device at 6 months

Secondary study objectives

Successful cannulation on or before Postoperative Day 7

Sustained use

Other study objectives

Assisted Primary Patency Rate

Change from baseline Patient Reported Outcomes Measures/Patient Reported Experience Measures (PROM/PREM) survey (SF-VAQ);

Days of central venous catheter insitu

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: InnAVasc AVG treatmentExperimental Treatment1 Intervention

Patients will be surgically 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 looped configuration in the forearm (forearm loop) or upper arm (axillary loop).

0 / 10Eligibility criteria met