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Arteriovenous Graft

InnAVasc Graft for Kidney Failure

N/A

Waitlist Available

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)

For patients NOT on Coumadin / warfarin, international normalized ratio (INR) ≤1.5

Must not have

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

Treatment with any investigational drug or device within 30 days prior to enrollment

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 study if a new kind of dialysis access graft is safe and effective. The new graft has been designed to allow for immediate needle access, reduce excessive bleeding, and provide protection from improper needle cannulation attempts.

Who is the study for?

This trial is for adults aged 18-80 with end-stage renal failure who need a dialysis graft but can't have an autologous fistula. Candidates should have suitable anatomy for the graft, not be on strong blood thinners, and expect to live at least another year. Exclusions include severe heart disease, uncontrolled diabetes or hypertension, recent stroke or myocardial infarction, active infections or cancer treatment within a year (except certain skin cancers), and known clotting disorders.

What is being tested?

The study tests the InnAVasc arteriovenous graft's safety and effectiveness in hemodialysis patients with kidney failure. This new type of graft may allow immediate use after surgery, potentially reduce bleeding post-dialysis, and offer protection against needle misplacement compared to standard dialysis grafts.

What are the potential side effects?

Potential side effects could include complications from surgery such as infection or bleeding at the implant site. There might also be issues related to dialysis like clotting of the new graft or problems due to incorrect needle placement during dialysis.

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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My blood clotting time is normal and I'm not on Coumadin/warfarin.

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I have end-stage renal disease and cannot have a natural fistula, so I need an artificial 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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I haven't used any experimental drugs or devices in the last 30 days.

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I haven't had cancer treatment in the past year, except for non-invasive skin cancer.

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My diabetes is severe with an HbA1c over 10%.

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I do not have severe heart problems or recent heart attacks.

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

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I have severe artery problems in the limb chosen for my medical device.

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I have a bleeding condition not related to kidney failure.

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

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 (AESIs) Through 6 Months

Secondary Patency of InnAVasc AVG at 6 Months

Secondary study objectives

Number of Participants With Functional Patency of InnAVasc AVG at 3, 6, 12, 18, and 24 Months

Time to Successful Cannulation of the InnAVasc AVG

Other study objectives

Change From Baseline of Patient Reported Outcomes Measures / Experience Measures

Health Economics Derived From Collected Study Data

Incidence of Individual Adverse Events

+2 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: InnAVasc AVG treatmentExperimental Treatment1 Intervention

Patients will be surgically implanted with an InnAVasc AVG 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 / 12Eligibility criteria met