RecruitingOBSERVATIONAL

Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access

This study is for people with severe kidney disease who need dialysis. It's looking at a specific medical device called a GORE ACUSEAL Vascular Graft, which is like a special tube that helps connect to a dialysis machine. The main goal is to check how safe and effective this graft is over two years. Researchers will follow around 70 patients who have this graft implanted as part of their regular care. They'll be watching to see how well the graft works and if there are any device-related infections. This is an observational study, meaning patients will receive their usual treatment, and doctors will simply observe how the graft performs in a real-world setting.

At a glance

Status

Recruiting

Sponsor

W.L.Gore & Associates

Enrolment target

Start

12 Jan 2024

Estimated completion

27 Oct 2027

Chronic Kidney Diseases End Stage Renal Disease on Dialysis

What is this study about?

If you have severe kidney disease, your kidneys might not be able to clean your blood properly. This is called End-Stage Renal Disease (ESRD). When this happens, you often need a treatment called haemodialysis, which uses a machine to clean your blood for you. To do this, doctors need a good way to get blood in and out of your body, and this is where a 'vascular access' comes in.

This study is looking at a particular type of vascular access called a GORE ACUSEAL Vascular Graft. Think of it as a special tube that surgeons put under your skin to create an easy and safe way to connect to the dialysis machine. Researchers want to see how well this graft works in everyday use and if it causes any problems, like infections, over two years. This helps them understand if it's a good and reliable option for people needing long-term dialysis.

The study involves observing about 72 patients across Europe who receive this graft as part of their usual treatment. It's not a study where you'd be given a new medicine or a different treatment than what your doctor thinks is best for you. Instead, it's about watching how the graft performs in real patients getting their normal care after the graft has been put in.

Key takeaways

This study looks at a special tube, the GORE ACUSEAL Vascular Graft, for dialysis.
It's for people with severe kidney disease needing haemodialysis.
The goal is to see how safe and effective the graft is over two years.
You'll get the graft as part of your regular care; no new treatments.
Researchers will observe your health for 24 months during normal check-ups.
Your participation helps gather important information for future patients.

Who may be eligible?

To join this study, you must be an adult (18 years or older) who needs haemodialysis because of severe kidney disease. You should be planning to use the GORE ACUSEAL Vascular Graft for your dialysis access. This might be because you are already on dialysis or will start soon after getting the graft, and you expect to be on dialysis for at least 12 months. You also need to be willing to come to your regular follow-up appointments.

There are also some reasons why you wouldn't be able to join. For example, if you have a known infection, are pregnant or breastfeeding, or have had certain other medical procedures on your arm recently. If you have a known problem with blood clotting or a severe reaction to heparin, you also wouldn't be able to take part. Also, if you are currently in another research study or being considered for a kidney transplant from a living donor, this study wouldn't be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you need a graft for haemodialysis because of severe kidney disease?
Are you willing to use the GORE ACUSEAL Vascular Graft for your dialysis access?
Can you attend your regular hospital follow-up appointments?
Are you not currently on certain immunosuppressant medicines (like more than 10mg prednisone)?
Are you not currently in another medical research study or being considered for a living donor kidney transplant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first need to read and sign a consent form, which explains everything about the study in detail. After that, you'll have the GORE ACUSEAL Vascular Graft implanted as part of your normal treatment. You won't be given any special study medication; you'll continue with your usual medical care.

Researchers will then follow your progress for 24 months (two years). During this time, you'll attend your regular hospital check-ups, just as you normally would. The study will simply collect information from these visits to understand how the graft is performing and if it causes any problems. There aren't any extra study visits beyond your standard medical care.

Potential risks and benefits

This study aims to gather real-world information about how well and safely the GORE ACUSEAL Vascular Graft performs for dialysis access. For you as a participant, the main benefit is knowing you are contributing to important medical knowledge that could help future patients. There are no extra medical benefits beyond receiving the best standard care for your condition. Potential risks are generally those associated with any surgical procedure to implant a vascular graft, such as infection or bleeding, but these are part of your standard medical care and not specifically because of the study. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Evangelisches Klinikum Bethel (EvKB)
Verified postcode
Bielefeld, Germany· Recruiting
Ev. DiakonissenKrankenhaus Leipzigemeinnützige
Verified postcode
Leipzig, Germany· Recruiting
ASST-Settelaghi Ospedale di Circolo e Fondazione Macchi
Verified postcode
Varese, Italy· Recruiting
North Bristol NHS Trust Southmead Hospital
Verified postcode
Bristol, United Kingdom· Recruiting
King's College Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Not yet recruiting

Common questions

What is a GORE ACUSEAL Vascular Graft?

It's a special tube or a 'graft' that surgeons put under your skin to create a reliable entry point for haemodialysis treatment in people with severe kidney disease.

Will I receive new medicine or different treatment in this study?

No, this study is observational. You'll receive the GORE ACUSEAL Vascular Graft as part of your usual care, and researchers will simply watch how it performs without changing your treatment.

How long will I be involved in the study?

If you join, researchers will follow your progress for 24 months, which is two years, gathering information during your regular hospital visits.

Are there any extra appointments I need to go to?

No, there are no extra appointments specifically for the study. You will attend your standard medical check-ups as usual, and the study will gather information from those.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any point without needing a reason, and it won't affect your medical care.

How to find out more

Elisabetta Ferro

eferro@wlgore.com +39 3486244749 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.