Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access

Launched by W.L.GORE & ASSOCIATES · Apr 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a device called the GORE® ACUSEAL Vascular Graft for patients with chronic kidney disease who are on hemodialysis. The main goal is to find out if this graft can be safely used for creating vascular access, which is essential for dialysis treatment, and to see how well it works over a 24-month period. Participants will be monitored for any infections related to the graft and how well it continues to function during that time.

To be eligible for this study, participants must be at least 18 years old, need a new access point for hemodialysis, and expect to be on dialysis for at least the next year. They also need to agree to follow up with their healthcare providers as required. Individuals with certain health conditions, such as infections or specific blood disorders, and those who are pregnant or breastfeeding cannot participate. If enrolled, participants will receive the graft and will be followed for two years to ensure their safety and the performance of the device.

Gender

ALL

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.