At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- GORE® ACUSEAL Vascular Graft (device)
- How long the study runs
- Study runs about 45 months (dates as stated)
- About the drug or intervention
- GORE® ACUSEAL Vascular Graft — device: The device placement will be performed according to each participating site's standard practice.
- Patient visit burden
- Not specified by the sponsor
In plain English
This registry collects information from people with end-stage kidney disease who need a vascular graft (a special tube called the GORE® ACUSEAL Vascular Graft) to create access for haemodialysis, a treatment that filters the blood. The sponsor is W.L. Gore & Associates.
Who can take part
- Adults aged 18 or over who sign a consent form
- Need vascular access for haemodialysis (blood filtering treatment) because of end-stage kidney disease, and the GORE® ACUSEAL graft will be used
- Currently on haemodialysis, or starting it right after the graft is placed or within 30 days
- Expected to stay on haemodialysis for 12 months
- Willing to attend standard follow-up care
Who may not be able to
- Have a known or suspected infection in the body
- Are pregnant or breastfeeding
- Had a vascular procedure or operation on the same limb within the last 30 days
- Have an untreated narrowing of the large veins on the same side, confirmed by imaging
- Take certain medicines that suppress the immune system or regular steroid tablets above 10 mg
- Have a blood clotting or bleeding disorder
- Have had a serious reaction to heparin (a blood thinner) called HIT-2, or are sensitive to heparin
- Are taking part in another research study, or already took part in this registry
- Are being considered for a kidney transplant from a living donor
- Have a life expectancy of less than 2 years
What taking part involves
- • Surgery to place the GORE® ACUSEAL Vascular Graft to create access for haemodialysis
- • Follow-up care at your hospital, as per standard practice
Time commitment: Not stated — ask the trial team about number of visits and exact duration; the data says patients are expected to remain on haemodialysis for 12 months and attend standard follow-up.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 72
- Started
- 2024-01-12
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for chronic kidney diseases
- • Clinical study - 72 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with chronic kidney diseases
Where?
- • Bristol - North Bristol NHS Trust Southmead Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This is a European, Observational, Non-Interventional, Prospective, Non-Randomized, Single Arm, Multicenter, PMCF Registry to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. There is no comparator device. The aim of study is to obtain real-world observational evidence about the use of the device. The AVG 22-09 registry consists of End-Stage Renal Disease (ESRD) patients who require hemodialysis access through Vascular Graft per the evaluating physician. A total of 72 subjects will be implanted in this registry with a limit of 25 subjects implanted per site. The registry has been designed with standard eligibility criteria to enroll subjects for which the registry device is intended to treat. Only patients who meet all of the inclusion criteria and none of the exclusion criteria will be implanted. All patients must provide informed consent prior to any registry related procedures being performed and the patient is considered enrolled when informed consent is obtained. The primary objective is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft in hemodialysis access for the treatment of Chronic Kidney Disease (CKD) in patients with End Stage Renal Disease (ESRD). All patients who sign an informed consent will be considered enrolled and at the completion of study participation, subjects will be advised by their respective clinical centers on the appropriate follow up regimen to be followed but it is expected that the each implanted subject will be evaluated through hospital discharge and return for follow-up visits per site standard of care. Each enrolled and implanted subject will be followed for 24 months.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Age ≥18 years at time of agreement to take part Form (ICF) signature.
- ✓Willingness of the patient to adhere to institutional the usual treatment follow-up.
- ✓agreement to take part Form (ICF) is signed by the patient.
- ✓The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
Who cannot take part
- ✗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...
- ✗The patient had a previous documented (via imaging technique) and unsuccessfully treated ipsilateral central venous...
- ✗The patient has a known hypercoagulability or bleeding disorder.
See the full criteria
Where Is This Study? (1 UK site)
North Bristol NHS Trust Southmead Hospital
Bristol BS10 5NB, United Kingdom
How to Get in Touch
Elisabetta Ferro
Sponsor contactCONTACT