RecruitingNCT05846581

Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access

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

Sponsor

W.L.Gore & Associates

Enrollment

72 participants

Start Date

Jan 12, 2024

Study Type

OBSERVATIONAL

Conditions

Chronic Kidney Diseases End Stage Renal Disease on Dialysis

Summary

The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. The main questions it aims to answer are: * Safety: Freedom from device-related infection adverse events at 24 months from device implant * Performance: Secondary patency at 24 months from device implant. Participants, after informed consent is obtained, will be implanted with GORE® ACUSEAL Vascular Graft and followed for 24 months in standard of care, to evaluate safety and performance of the device.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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.
Age ≥18 years at time of Informed Consent Form (ICF) signature.
Willingness of the patient to adhere to institutional standard of care follow-up.
Informed Consent Form (ICF) is signed by the patient.
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.
The patient has a reasonable expectation of remaining on hemodialysis for 12 months.

Exclusion Criteria11

The patient currently has a known or suspected systemic infection.
The patient is pregnant or breastfeeding.
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.
The patient had a previous documented (via imaging technique) and unsuccessfully treated ipsilateral central venous stenosis.
The patient is currently taking maintenance corticosteroids and immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (\> 10 mg), cyclosporine, tacrolimus, or cyclophosphamide.
The patient has a known hypercoagulability or bleeding disorder.
The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to Heparin.
The patient is enrolled in an investigational study.
The patient has been previously enrolled in this registry.
The patient is currently being considered for a live donor kidney transplant (living donor either related or unrelated to patient).
The patient has life expectancy less than 2 years.

Interventions

DEVICEGORE® ACUSEAL Vascular Graft

The device placement will be performed according to each participating site's standard practice. No specific procedures are required by the protocol. At the time of the GORE® ACUSEAL Vascular Grafts implantation, procedural and adverse event information will be collected.