Active not recruitingOBSERVATIONAL

Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry

This study is gathering real-world information about a special medical device called the GORE VIABAHN Endoprosthesis, which has a PROPATEN Bioactive Surface. This device is a type of covered tube (stent) that doctors use in arteries. The study is observing people who have already been treated with this device for various conditions, including common circulation problems in the legs (Peripheral Artery Disease), ballooning or weakening of artery walls (aneurysms), or to help with dialysis access. By watching how these patients do over several years, doctors hope to learn more about how well the device works and its safety in everyday practice. This is not a study where new treatments are tested but rather an observation of existing patient care.

At a glance

Status

Active not recruiting

Sponsor

W.L.Gore & Associates

Enrolment target

614

Start

09 Oct 2021

Estimated completion

01 Oct 2035

Peripheral Artery Disease Popliteal Aneurysm Hemodialysis Access Visceral Artery Aneurysms Trauma Injury

What is this study about?

This study, called the Observational GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface Global Registry, is designed to collect information on how a specific medical device performs in patients in real-world situations. The device is a special covered tube or stent, known as the GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface. It's used to treat various conditions affecting blood vessels.

Doctors use this device for several problems, including narrowed or blocked arteries in the legs (peripheral artery disease), weakened or abnormally widened arteries like in the knee or other areas (popliteal or visceral artery aneurysms), and for maintaining access for kidney dialysis treatment. It can also be used in cases of injury to blood vessels. This study is simply observing patients who have already received this device as part of their standard medical care, rather than testing a new treatment.

The main goal is to understand how well the device works, how safe it is, and if there are any long-term effects. This information helps medical professionals and manufacturers ensure the device is performing as expected and helps improve patient care in the future. Around 35 medical centres across Europe are taking part, aiming to follow at least 614 patients for several years, depending on their specific condition.

Key takeaways

This study observes how a specific medical device (GORE VIABAHN Endoprosthesis) performs in real-world patients.
It helps doctors understand the long-term safety and effectiveness of the device for various artery conditions.
Participation involves allowing your health information from existing medical appointments to be collected.
You would not receive any new or experimental treatments as part of this study.
The information gathered aims to improve future patient care and understanding of the device.

Who may be eligible?

To be part of this observational study, you would generally need to be 18 years or older and have a doctor decide that the GORE VIABAHN Endoprosthesis is the right treatment for your condition. You'd also need to be willing to regularly attend your follow-up appointments.

There are certain situations where you might not be suitable for this study. For example, if your arteries are too narrow or difficult to treat with this specific device, or if you have severe allergies to the materials used in the device or certain medications like heparin or contrast dye. Also, if you are pregnant or breastfeeding, or have other serious health issues that doctors believe would make it difficult to properly assess the device, you would likely not be included. It's important that your doctor believes this device is the best option for you and that you can manage the follow-up care involved.

Quick self-check

Are you 18 years of age or older?
Has your doctor decided that the GORE VIABAHN Endoprosthesis is the right treatment for you?
Are you willing to attend your regular follow-up appointments as advised by your doctor?
Do you have severe allergies to heparin, contrast dye, or any materials in the device?
Are you currently pregnant or breastfeeding?
Do you have any other serious health conditions that your doctor thinks might affect the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you participate in this study, it actually means you've already had the GORE VIABAHN Endoprosthesis fitted as part of your normal treatment. You won't receive a new or experimental treatment just for the study. Your involvement will mainly consist of your regular follow-up appointments with your doctor, which you would have anyway. At these appointments, the study team will collect information about how you're doing, how the device is performing, and any health events you experience. The length of follow-up varies depending on your condition, from one year for conditions like trauma, to as long as ten years for popliteal artery aneurysms. There are no additional medications specifically for the study. You're simply allowing your health information related to the device to be recorded for research purposes.

Potential risks and benefits

Since this is an observational study, and you would have already received the device as part of your standard medical care, there are no additional direct medical risks or benefits from being in the study itself. The potential benefits are for future patients, as the information gathered will help doctors better understand the long-term performance and safety of the GORE VIABAHN Endoprosthesis. The potential risks are those associated with the original medical procedure and the device itself, which your treating doctor would have already discussed with you. You always have the right to withdraw your consent for your data to be collected for the study at any time, without affecting your medical treatment.

Locations (26)

iD3 Medical cvba
Sint-Agatha-Berchem, Belgium
Centre Hospitalier Unversitaire d'Angers
Angers, France
Centre Hospitalier Regional Universitaire de Brest
Brest, France
Hopital Edouard Herriot (HCL)
Lyon, France
Hospital Paris Saint-Joseph
Paris, France
Clinique RHENA
Strasbourg, France
Cardioangiologisches Centrum Bethanien
Frankfurt, Germany
Marien Krankenhaus
Hamburg, Germany
University of Heidelberg
Heidelberg, Germany
Krankenhaus Reinbek St. Adolf-Stift
Reinbek, Germany
University Hospital Tuebingen
Tübingen, Germany
Papageorgiou Hospital
Pávlos, Greece

+14 more sites — see the official record for the full list.

Common questions

What is the GORE VIABAHN Endoprosthesis?

It's a special type of covered tube or stent that doctors use to help blood flow in damaged or narrowed blood vessels.

Am I being given a new treatment for this study?

No, this study only observes patients who have already received the device as part of their regular medical care. No new or experimental treatments are given.

How long will I be followed up?

The follow-up period varies depending on your medical condition, ranging from one year to ten years, as part of your normal medical care.

Will my regular doctor appointments change?

No, your follow-up appointments will be the same as recommended by your doctor for your condition. The study simply collects information from these visits.

Are there any extra costs for me if I take part?

No, there are no additional costs associated with participating in this observational study.