Evaluating GORE® ACUSEAL Vascular Graft for Dialysis Access

Observational Prospective Post-Market Clinical Follow-Up (PMCF) Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access

This study is testing a new type of vascular graft to see if it is safe and effective for people with kidney failure who need access for hemodialysis.

Quick facts

• Study type: Observational
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: W.L.Gore & Associates (Industry-sponsored)
• Drugs / interventions: cyclophosphamide, prednisone
• Locations: 5 sites (Bielefeld and 4 other locations)
• Trial ID: NCT05846581 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety and performance of the GORE® ACUSEAL Vascular Graft in patients with End Stage Renal Disease (ESRD) requiring hemodialysis access. Participants will be implanted with the graft and followed for 24 months to monitor for device-related infections and the graft's secondary patency. The study is non-interventional and will gather real-world evidence from multiple centers across Europe. A total of 72 subjects will be enrolled, with each site limited to 25 participants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who require vascular access for hemodialysis due to End Stage Renal Disease.

Not a fit: Patients with known systemic infections or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the safety and effectiveness of vascular access for patients undergoing hemodialysis.

How similar studies have performed: Other studies evaluating vascular grafts for hemodialysis access have shown promising results, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Bielefeld and 4 other locations

• Evangelisches Klinikum Bethel (EvKB) — Bielefeld, Germany (Recruiting)
• Ev. DiakonissenKrankenhaus Leipzigemeinnützige — Leipzig, Germany (Recruiting)
• ASST-Settelaghi Ospedale di Circolo e Fondazione Macchi — Varese, Italy (Recruiting)
• North Bristol NHS Trust Southmead Hospital — Bristol, England, United Kingdom (Recruiting)
• King's College Hospital NHS Foundation Trust — London, England, United Kingdom (Not_yet_recruiting)

Study contacts

• Principal investigator: Matteo Tozzi — University of Insubria (Italy)
• Study coordinator: Elisabetta Ferro

Conditions Chronic Kidney Diseases; End Stage Renal Disease on Dialysis; Post-Market Clinical Follow-Up; End Stage Renal Disease; Hemodialysis; vascular graft