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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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.