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Stent

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

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.
Must not have
Patient has evidence of a systemic infection.
Patient has had vascular catheterization of the lower extremities within 30 days of randomization (excluding diagnostic angiograms for the study procedure).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a systemic infection.
Select...
I had a procedure for my leg veins within the last 30 days.
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I need surgery to improve blood flow in my leg.
Select...
My kidney function is low (creatinine > 2.5mg/dL), and I am not on dialysis.
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I have had surgery to reroute blood flow in my limb.
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I need a stent near my groin area.
Select...
I need a special procedure to prepare for stent placement in my blood vessel.
Select...
I have a problem with the main artery in my abdomen.
Select...
I have a blockage in one main pelvic artery that can be fixed with one procedure.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Patency
Secondary study objectives
Acute procedural success
Amputation-free survival
Change in EQ-5D-5L
+13 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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)

Find a Location

Who is running the clinical trial?

W.L.Gore & AssociatesLead Sponsor
100 Previous Clinical Trials
32,545 Total Patients Enrolled

Media Library

Bare Metal Stent (Stent) Clinical Trial Eligibility Overview. Trial Name: NCT05811364 — N/A
Peripheral Artery Disease Research Study Groups: BMS Control Group, VBX Device Group
Peripheral Artery 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
~163 spots leftby Apr 2027
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