Actively Recruiting
Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
Led by W.L.Gore & Associates · Updated on 2025-07-09
72
Participants Needed
5
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient requires vascular access creation for hemodialysis due to End-Stage Renal Disease and plans to use GORE4 ACUSEAL Vascular Graft for arteriovenous access
- Age 18 years or older at time of informed consent
- Willing to follow institutional standard care for follow-up
- Signed informed consent form
- Currently on hemodialysis or expected to start hemodialysis within 30 days after graft placement
- Expected to remain on hemodialysis for at least 12 months
You will not qualify if you...
- Known or suspected systemic infection
- Pregnant or breastfeeding
- Had vascular surgery or intervention on the study limb within 30 days before graft placement
- Previously had unsuccessfully treated central venous stenosis on the same side
- Taking maintenance corticosteroids or immunosuppressants such as rapamycin, mycophenolate, prednisone over 10 mg, cyclosporine, tacrolimus, or cyclophosphamide
- Known blood clotting or bleeding disorder
- History of Heparin Induced Thrombocytopenia type 2 or sensitivity to Heparin
- Currently enrolled in another investigational study
- Previously enrolled in this registry
- Being considered for a live donor kidney transplant
- Life expectancy less than 2 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Evangelisches Klinikum Bethel (EvKB)
Bielefeld, Germany, 33611
Actively Recruiting
2
Ev. DiakonissenKrankenhaus Leipzigemeinnützige
Leipzig, Germany, 04177
Actively Recruiting
3
ASST-Settelaghi Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Actively Recruiting
4
North Bristol NHS Trust Southmead Hospital
Bristol, England, United Kingdom, BS10 5NB
Actively Recruiting
5
King's College Hospital NHS Foundation Trust
London, England, United Kingdom, SE5 9RS
Not Yet Recruiting
Research Team
E
Elisabetta Ferro
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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