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New graft aims to make dialysis safer for kidney patients

NCT ID NCT04671771

Disease control Sponsor: W.L.Gore & Associates Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new device called the InnAVasc graft, which is surgically placed in the arm to provide a reliable access point for hemodialysis in people with end-stage kidney disease. About 133 participants will receive the graft and be followed for two years to see how well it works and how safe it is. The main goals are to keep the graft functioning at 6 months and to track any serious side effects like infection or bleeding.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
InnAVasc Arteriovenous Graft (a surgical implant for dialysis access)
What this could lead to
If successful, this graft could provide a safer, more reliable option for dialysis access in people with kidney failure, reducing complications like infection or bleeding.
What could go wrong
This is a mid-stage study with 133 participants, so results may not apply to everyone. The graft could still fail or cause serious side effects like infection or blockage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 133 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2020

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Pre-Operative Inclusion Criteria: Patients must meet the following criteria at screening in order to be scheduled for a procedure and potentially enrolled in the study: 1. Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy; 2. Age 18 to 90 years old, inclusive; 3. Suitable anatomy for implantation of upper arm "straight" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow); 4. Ability to continue or commence antiplatelet therapy post graft implant (anticoagulation medication is acceptable if the subject is required to take an anticoagulant for a baseline medical condition); 5. Able and willing to give informed consent; 6. Anticipated life expectancy of at least 1 year. Intra-Operative Inclusion Criteria: Both vessels have been exposed and are deemed appropriate for implantation (i.e., based on the surgeon's opinion, artery is of adequate size, has adequate pulse to support AV access flow, is without significant calcification, and is safely clampable; and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction). Pre-Operative Exclusion Criteria: Patients will be excluded from the study at screening if they exhibit any of the following exclusion criteria: 1. History or evidence of severe cardiac disease (i.e., debilitating heart failure, or high risk of MI) in the opinion of the investigator which may preclude participation in and completion of the study; 2. Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations); 3. For upper arm straight configuration, an antecubital fossa crease to axillary crease distance \< 18 cm; 4. History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e., arterial inflow insufficient to support hemodialysis access); 5. Known or suspected central vein stenosis or obstruction on the side of planned graft implantation; 6. Baseline hypotension or history of frequent hypotensive episodes during dialysis that, in the opinion of the investigator, puts the patient at increased risk of graft thrombosis; 7. Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness); 8. Baseline hemoglobin \<7 g/dL; 9. Baseline platelet count \<50,000 or \>500,000 cells/mm3; 10. Documented history of stroke within 6 months prior to enrollment; 11. Treatment with any investigational drug or device within 30 days prior to enrollment; 12. Female patients who are pregnant, intending to become pregnant, nursing or intending to breastfeed during the study (pregnancy test may only be omitted, if patient is post-menopausal or has a documented history of hysterectomy or permanent sterilization); 13. History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin; 14. Immunodeficiency including documented history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) or patients receiving immunosuppressive therapy for treatment of an acute inflammatory event or autoimmune flare. Chronic immunosuppressive therapy is acceptable; 15. Documented or suspected hypercoagulable condition; 16. Bleeding diathesis, other than that associated with ESRD; 17. Documented history of heparin-induced thrombocytopenia (HIT); 18. Active local or systemic infection as documented from the medical history or bloodwork/blood culture data. If the infection resolves, the subject must be at least one-week post resolution of that infection before implantation; 19. Scheduled renal transplant within 6 months; 20. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and effectiveness of the IG; 21. Patient is unable or unwilling to complete all required follow-up assessments and questionnaires.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome end stage renal failure kidney failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic renal disease End-stage renal disease (ESRD) Hemodialysis Kidney failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AKDHC Medical Research Services, LLC

    RECRUITING

    Phoenix, Arizona, 85012, United States

  • Baylor Heart and Vascular

    NOT_YET_RECRUITING

    Dallas, Texas, 75246, United States

  • Brigham & Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Guthrie Clinic

    RECRUITING

    Sayre, Pennsylvania, 18840, United States

  • Houston Methodist Hopsital

    RECRUITING

    Houston, Texas, 77030, United States

  • Medical University of South Carolina

    RECRUITING

    Orangeburg, South Carolina, 29118, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • NC Heart and Vascular Research, LLC

    ACTIVE_NOT_RECRUITING

    Raleigh, North Carolina, 27607, United States

  • Northwell Health

    RECRUITING

    New York, New York, 10075, United States

  • Piedmont Augusta

    RECRUITING

    Augusta, Georgia, 30901, United States

  • Prisma Health- Upstate

    RECRUITING

    Greenville, South Carolina, 29615, United States

  • Rutgers

    RECRUITING

    Newark, New Jersey, 07103, United States

  • Sarasota Memorial Hospital

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Surgical Specialists of Charlotte

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • WakeMed

    RECRUITING

    Raleigh, North Carolina, 27610, United States

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