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Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease

This research study is looking at how well a device called the GORE VIABAHN VBX stent works in real patients. This stent is used for a treatment called CERAB, which helps clear blockages in the main artery (aorta) that goes to your legs, a condition known as aortoiliac occlusive disease. The study aims to understand how safe and effective this stent is in everyday medical practice. Instead of new tests, researchers will look at health records of adult patients who have already had this procedure at various hospitals in the UK, Europe, and the US. They want to see how patients have been doing after their treatment, gathering information from their existing medical files.

At a glance

Status
Recruiting
Sponsor
W.L.Gore & Associates
Enrolment target
158
Start
30 May 2025
Estimated completion
16 Aug 2027

What is this study about?

This study is about a medical condition called aortoiliac occlusive disease. This happens when the large artery that carries blood from your heart down to your legs (the aorta) and its main branches become narrowed or blocked. This can cause pain when walking or even at rest.

The study is specifically looking at a treatment for this condition called CERAB, which stands for Covered Endovascular Reconstruction of the Aortic Bifurcation. During this procedure, a special device called the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (or VBX stent) is used to open up the blocked arteries and keep them open. This stent is placed inside the artery using a thin tube, without major surgery.

Researchers want to collect information from people who have already had this CERAB procedure with the VBX stent. They want to see how safe and effective the stent has been in real-world situations, rather than in a new clinical trial. This helps doctors understand more about the treatment over time and ensure it's providing good results for patients.

Key takeaways

  • Aims to understand how well a specific stent (VBX) works for blocked leg arteries.
  • Only uses information from existing patient medical records, no new tests.
  • Focuses on patients who have already had the CERAB procedure with the VBX stent.
  • Looks at past health information from at least one year after the procedure.
  • No impact on your current or future medical treatment.
  • Helps improve understanding of treatment outcomes for future patients.

Who may be eligible?

To be included in this study, you must be an adult aged 18 or older who has already had the CERAB procedure to treat aortoiliac occlusive disease. This procedure must have involved implanting the VBX stent in the main artery (aorta) and must have taken place at least one year before the study began looking for participants. You (or your legal representative) would also need to agree to let the researchers look at your existing medical records.

However, you wouldn't be able to be part of this study if you had received another stent in your main artery or the iliac artery (a branch off the aorta) before your CERAB procedure. Also, if you had a different type of procedure called a 'chimney procedure' at the same time as your CERAB procedure, you wouldn't qualify. Finally, if you were involved in another research study that might affect the findings of this one around the time of your CERAB procedure, you also wouldn't be eligible.

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.

  1. Are you 18 or older?
  2. Have you had the CERAB procedure for blocked leg arteries?
  3. Was a VBX stent used in your main artery during that procedure?
  4. Did you have this procedure at least one year ago?
  5. Did you NOT have another stent in your aorta/iliac artery before your CERAB procedure?
  6. Were you NOT involved in any other confusing drug/device studies at the time of your CERAB?
Answer every question to see your result.

What does participation involve?

If you are eligible, taking part in this study would involve allowing researchers to look at your existing medical records from your hospital visits. They will collect information that was already written down during your initial treatment, when you left the hospital, and during any follow-up appointments you've already had. This includes your visit about a year after your procedure and any visits since then. You won't need to have any new tests, take any new medication, or attend any extra appointments just for this study; everything they need will come from your past medical care. The study is about collecting information that already exists, so there are no new procedures or follow-ups required from you.

Potential risks and benefits

Because this study only involves looking at existing medical records, there are no direct benefits or physical risks to you from participating. Your medical care will not change. The information gathered may help doctors better understand the use of the VBX stent for future patients. You have the right to withdraw your consent for your information to be used at any time without affecting your medical treatment.

Locations (25)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of California
    Verified postcode
    Fresno, United States· Recruiting
  • University of South Florida
    Verified postcode
    Tampa, United States· Recruiting
  • Mayo Clinic Rochester
    Verified postcode
    Rochester, United States· Recruiting
  • Cooper University Hospital
    Verified postcode
    Camden, United States· Recruiting
  • Rutgers
    Verified postcode
    New Brunswick, United States· Recruiting
  • Research Foundation SUNY Buffalo
    Verified postcode
    Buffalo, United States· Recruiting
  • Mount Sinai Medical Center
    Verified postcode
    New York, United States· Recruiting
  • Research Foundation at SUNY Syracuse
    Verified postcode
    Syracuse, United States· Recruiting
  • Atrium Health Sanger Heart & Vascular Institute
    Verified postcode
    Charlotte, United States· Recruiting
  • Ohio State University Medical Center
    Verified postcode
    Columbus, United States· Recruiting
  • Geisinger Medical Center
    Verified postcode
    Danville, United States· Recruiting
  • University Of Pennsylvania
    Verified postcode
    Philadelphia, United States· Recruiting

Common questions

What is aortoiliac occlusive disease?

It's a condition where the main artery carrying blood to your legs and its branches get narrowed or blocked, which can cause pain.

What is the CERAB procedure?

It's a treatment where a special stent, like the VBX stent, is used to open up blocked arteries in your leg pathway.

Will I have to have any new tests or appointments?

No, this study only looks at your existing medical records; you won't have any extra tests or appointments.

Does taking part affect my medical care?

No, your medical care will not change, and you can withdraw from the study at any time without affecting your treatment.

What is the purpose of collecting old data?

It helps doctors understand how safe and effective the VBX stent has been for patients in real-life situations over time.

How to find out more

Jennifer Camoriano, BS

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

Interested in taking part?

Register your interest

Share your details and the research team for "Real-World Data Collection of the GORE® VIABAHN® VBX Balloon…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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