Clinical Trials in Germany / NCT05846581
Recruiting
Observational
Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
NCT05846581 · tracked via the Priya Life Science Germany tracker
Condition(s) studied
Chronic Kidney DiseasesEnd Stage Renal Disease on Dialysis
Investigational drug(s) / intervention(s)
GORE® ACUSEAL Vascular Graft
GORE® 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.
Study 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
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.
Primary outcome measure(s)
- Primary Safety Endpoint. Number of subjects free from device-related infection at 24 months from device implant. — 24 months from device implant
Events will be computed as follows: 1. All subjects who had a registry device related AE with an Infection MedDRA code within 730 days from device implant will be tabulated as 'Not Free from Infection'. 2. All subjects who completed the registry and were infection free at 24 months from the registry procedure will be considered free from device related infection. All relevant infection MedDRA terms will be agreed upon by the Office of Medical Affairs within Gore. This endpoint will be treated as a patient-based binomial proportion, and no formal hypothesis will be tested. A Kaplan Meir analysis will also be done to account for censoring. - 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. — 24 months from device implant
Events will be computed as follows: 1. All subjects who have an abandonment or explant of the registry graft within 730 days will have lost secondary patency. The date will be noted on the discontinuation form. 2. All subjects who completed the registry within 730 days without a graft abandonment will be considered patent. 3. If a subject did not complete the registry for a reason other than graft abandonment or explant, they will be censored. A Kaplan Meir analysis will be done to account for censoring.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | Terminated |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05846581 on ClinicalTrials.gov ↗ ← All trials in Germany