Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access (NCT05846581) | Clinical Trial Compass
RecruitingNot Applicable
Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
Germany, Italy, United Kingdom72 participantsStarted 2024-01-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. The patient currently has a known or suspected systemic infection.
✕. The patient is pregnant or breastfeeding.
✕
What they're measuring
1
Primary Safety Endpoint. Number of subjects free from device-related infection at 24 months from device implant.
Timeframe: 24 months from device implant
2
Primary Performance Endpoint. Secondary Patency at 24 months: The time from device implant to complete abandonment of the access site for hemodialysis regardless of the number of interventions required to restore or maintain patency.
. 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.