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Stent

VBX Balloon Expandable Endoprosthesis vs Bare Metal Stent for Peripheral Arterial Disease

Q: Are there any vacant slots available for participation in this experiment?

<p>According to clinicaltrials.gov, this research project is no longer recruiting participants; its original posting was on July 31st 2023 and the last update was March 30th 2023. Nevertheless, there are still 218 other trials actively searching for volunteers currently.</p>

Q: How many medical facilities are conducting the experiment?

<p>Seven medical centres are enrolling patients in this research project. These include University of <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a> (Philadelphia), the University of <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> Southwestern Medical Centre (Dallas) and Texas Tech University Health Science Center (Lubbock). There are also four other sites participating.</p>

N/A

Recruiting

Research Sponsored by W.L.Gore & Associates

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has symptomatic claudication, rest pain, or minor tissue loss (Rutherford Category 2-5)

Patient has at least one sufficient (<50% stenotic) infrapopliteal run-off vessel.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 5 years

Awards & highlights

Study Summary

This trial will compare two techniques for treating complex blockages in the iliac artery to see which is more successful.

Who is the study for?

Adults over 18 with complex iliac occlusive disease, who can follow the study plan and have specific types of blockages in their pelvic arteries. They must not be pregnant, allergic to stent materials like nitinol or heparin, have severe kidney issues, recent lower extremity vascular procedures (except certain angiograms), previous iliac artery stents or surgeries, or require other leg artery treatments.Check my eligibility

What is being tested?

This trial is testing if the GORE VIABAHN VBX Balloon Expandable Endoprosthesis is better for keeping blood vessels open compared to traditional bare metal stents in patients with complicated blockages in the pelvic arteries.See study design

What are the potential side effects?

Potential side effects may include reactions at the insertion site such as pain or bleeding, infection risk, damage to surrounding blood vessels or organs from device placement and possible allergies to device materials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience leg pain when walking, pain at rest, or have minor tissue loss.

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I have at least one leg artery that is not majorly blocked.

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I have new or recurring blockage in my pelvic arteries.

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My leg arteries are mostly open, with less than half blocked.

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I am 18 years old or older.

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I have one or more narrowed or blocked arteries between 4 and 11 cm long.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Patency

Secondary outcome measures

Acute procedural success

Amputation-free survival

Change in EQ-5D-5L

+13 more

Trial Design

2Treatment groups

Active Control

Group I: BMS Control GroupActive Control1 Intervention

Subjects in this group will receive treatment with a commercially available bare metal stent (BMS) that is approved for treatment of the disease

Group II: VBX Device GroupActive Control1 Intervention

Subject in this group will receive treatment with the GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

W.L.Gore & AssociatesLead Sponsor

95 Previous Clinical Trials

27,940 Total Patients Enrolled

Media Library

Bare Metal Stent (Stent) Clinical Trial Eligibility Overview. Trial Name: NCT05811364 — N/A

Aortoiliac Occlusive Disease Research Study Groups: BMS Control Group, VBX Device Group

Aortoiliac Occlusive Disease Clinical Trial 2023: Bare Metal Stent Highlights & Side Effects. Trial Name: NCT05811364 — N/A

Bare Metal Stent (Stent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05811364 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacant slots available for participation in this experiment?

"According to clinicaltrials.gov, this research project is no longer recruiting participants; its original posting was on July 31st 2023 and the last update was March 30th 2023. Nevertheless, there are still 218 other trials actively searching for volunteers currently."

Answered by AI

How many medical facilities are conducting the experiment?

"Seven medical centres are enrolling patients in this research project. These include University of Pennsylvania (Philadelphia), the University of Texas Southwestern Medical Centre (Dallas) and Texas Tech University Health Science Center (Lubbock). There are also four other sites participating."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease

2023. "The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05811364.

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