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Can a new graft keep dialysis access working longer?

NCT ID NCT05846581

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study follows people with end-stage kidney disease who need a vascular graft for hemodialysis. The GORE ACUSEAL graft is placed to create a reliable access point for dialysis. Researchers will track how often the graft becomes infected and how long it stays functional, aiming to see if it holds up well over 24 months. The goal is to gather real-world evidence on the graft's safety and performance in routine clinical care.

What this could mean

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

Active substance
GORE® ACUSEAL Vascular Graft (a medical device used to create vascular access for hemodialysis)
What this could lead to
If successful, this could confirm that the GORE ACUSEAL graft is a safe and reliable option for long-term dialysis access, potentially improving outcomes for people with kidney failure.
What could go wrong
This is an observational study, not a randomized trial, so results may be influenced by patient differences. The graft may still carry risks like infection or blockage, and the study's findings depend on real-world follow-up.

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.

Participants

About 72 people

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

Started

Jan 2024

Expected to finish

Oct 2027

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.

Who is studied

Registry subject population - those patients with CKD in ESRD that require hemodialysis access through the GORE® ACUSEAL Vascular Graft meeting the inclusion and exclusion criteria will be eligible for screening for participation in this registry. The registry has been designed with broad eligibility criteria to capture real-world GORE® ACUSEAL Vascular Graft use, for which the device is intended to be implanted. Only patients who meet all of the inclusion criteria and none of the exclusion criteria will be implanted. No vulnerable populations are included in this registry.

Ages

18 years and older

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: 1. The patient requires the creation of vascular access for hemodialysis secondary to a diagnosis of End-Stage Renal Disease and intends to use GORE® ACUSEAL Vascular Graft device for arteriovenous (AV) access. 2. Age ≥18 years at time of Informed Consent Form (ICF) signature. 3. Willingness of the patient to adhere to institutional standard of care follow-up. 4. Informed Consent Form (ICF) is signed by the patient. 5. The patient is currently on hemodialysis or intended to begin hemodialysis immediately following placement of the GORE® ACUSEAL Vascular Graft device or up to 30 days following placement of the device. 6. The patient has a reasonable expectation of remaining on hemodialysis for 12 months. Exclusion Criteria: 1. The patient currently has a known or suspected systemic infection. 2. The patient is pregnant or breastfeeding. 3. The patient had a separate interventional or surgical vascular procedure within the study limb within 30 days prior to treatment with the GORE® ACUSEAL Vascular Graft device. 4. The patient had a previous documented (via imaging technique) and unsuccessfully treated ipsilateral central venous stenosis. 5. The patient is currently taking maintenance corticosteroids and immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (\> 10 mg), cyclosporine, tacrolimus, or cyclophosphamide. 6. The patient has a known hypercoagulability or bleeding disorder. 7. The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to Heparin. 8. The patient is enrolled in an investigational study. 9. The patient has been previously enrolled in this registry. 10. The patient is currently being considered for a live donor kidney transplant (living donor either related or unrelated to patient). 11. The patient has life expectancy less than 2 years.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome end stage renal failure

As listed by the trial registrant

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

Chronic kidney diseases End stage renal disease on dialysis

How to take part

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

  1. The places running it

    3 sites in 2 countries. 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

  • ASST-Settelaghi Ospedale di Circolo e Fondazione Macchi

    RECRUITING

    Varese, 21100, Italy

  • Ev. DiakonissenKrankenhaus Leipzigemeinnützige

    RECRUITING

    Leipzig, 04177, Germany

  • Evangelisches Klinikum Bethel (EvKB)

    RECRUITING

    Bielefeld, 33611, Germany

  • North Bristol NHS Trust Southmead Hospital

    TERMINATED

    Bristol, England, BS10 5NB, United Kingdom

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