Comparison of a new endoprosthesis to traditional stenting for iliac artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis against traditional bare metal stenting in patients suffering from complex iliac occlusive disease. It is a multicenter, randomized, controlled trial designed to demonstrate the superiority of the VBX device in achieving primary patency. Eligible participants will include those with symptomatic claudication or other related conditions and specific lesion characteristics in their iliac arteries. The study will assess outcomes related to blood flow restoration and symptom relief.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years at time of informed consent signature
* Informed Consent Form (ICF) is signed by the subject
* Subject can comply with protocol requirements, including follow-up
* Patient has symptomatic claudication, rest pain, or minor tissue loss (Rutherford Category 2-5)
* Patient has de novo or restenotic lesion(s) found in the common and/or external iliac artery(ies)
* Patient has: Unilateral or bilateral single or multiple lesions (\>50% stenosis or chronic total occlusion) each between 4 and 11 cm in length
* Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm
* Patient has a sufficient (\<50% stenotic) common femoral artery and at least one sufficient (\<50% stenotic) femoral artery (deep or superficial).
* Patient has at least one sufficient (\<50% stenotic) infrapopliteal run-off vessel.

Exclusion Criteria:

* Life expectancy \<1 year
* Patient is pregnant at time of informed consent.
* Patient has a known allergy to stent or stent graft components (including nitinol, stainless steel, or heparin).
* Patient has severe chronic renal insufficiency (serum creatinine level \> 2.5mg/dL) and not undergoing hemodialysis.
* Patient has evidence of a systemic infection.
* Patient has a known intolerance to antithrombotic medications that prevent compliance with study or control device Instructions for Use.
* Patient has had vascular catheterization of the lower extremities within 30 days of randomization (excluding diagnostic angiograms for the study procedure).
* Patient has previous stenting in the iliac arteries.
* Patient has previous surgical bypass in the target limb.
* Patient is currently participating in another investigative clinical study unless received written approval by the sponsor.
* Patient has a lesion requiring drug-coated balloon angioplasty, atherectomy, lithotripsy, or any ablative device to facilitate stent delivery.
* Patient has an abdominal aortic artery lesion or aneurysm.
* Patient has a lesion that requires stent placement within 2 cm of the inguinal ligament.
* Patient has isolated common iliac artery stenosis that can be treated with a single device (i.e., common iliac artery stenosis that does not require kissing stents or extend into the external iliac artery).
* Patient has outflow disease that requires concomitant interventions (i.e. common femoral endarterectomy or femoral / tibial revascularization).

Where it's running

• VA Long Beach Healthcare System
  Long Beach, California, United States Recruiting
• Denver Health and Hospital Authority
  Denver, Colorado, United States Recruiting
• University of Florida - Gainesville
  Gainesville, Florida, United States Recruiting
• Radiology and Imaging Specialists of Lakeland
  Lakeland, Florida, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• Atlanta VA Medical Center
  Decatur, Georgia, United States Recruiting

Study contacts

• Study coordinator: Alexander Ambrocik
• Email: aambroc@wlgore.com
• Phone: 337-387-4954

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.