A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System

Study Overview
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Brief Summary
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To determine the safety and effectiveness of the LUMINEXX stent for the proposed indication of treatment of common and/or external iliac artery occlusive disease

Detailed Description
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The study is designed to collect safety and efficacy data on the Bard Luminexx Iliac Stent in a broad patient population having indications for iliac stenting. Effectiveness in this study will be demonstrated by the prevention of Major Adverse Clinical Events (MACE). The composite primary endpoint of this clinical trial is freedom from peri-procedural death and freedom from stented segment revascularization or restenosis (>50%) at nine months.

Official Title
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A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System

Conditions
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Iliac Artery Occlusive Disease

Intervention / Treatment
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* Device: Bard Luminexx Iliac Stent and Delivery System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient or legal guardian understands procedure and provides written informed consent prior to study participation. Patient must be able and willing to comply with all study procedures including scheduled follow-up visits and diagnostic tests. Lesion(s) distinctly localized in the common and/or external iliac arteries. Reference lumen diameter (RLD) 6 mm and 9 mm. Stenosis 30% and symptomatic ischemic disease (Category 1-6 Chronic Limb Ischemia or Threatened or Irreversible Acute Limb Ischemia). Exclusion Criteria: Patients diagnosed with preoperative coagulation disorder or with contraindications to antiplatelet or anticoagulant therapy. Patients who are pregnant or planning to become pregnant during the clinical investigation. Patients with a life expectancy < 3 years. Patients currently or scheduled to be enrolled in another investigation that conflicts with follow-up testing or may confound the study data. Patients with absolute contraindication to x-ray contrast media or medications normally administered during an interventional procedure. Patients with severe tortuosity or angulation of a vessel that may prevent access in the opinion of the investigator. The presence of soft, thrombotic or embolic material within or adjacent to the lesion(s) being treated with the study device, in the opinion of the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iliac Stenting<br>Stent placement in the iliac artery | Device: Bard Luminexx Iliac Stent and Delivery System<br>* Iliac Stenting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Major Adverse Clinical Events (MACE) | Major Adverse Clinical Events defined as peri-procedural death (death during the procedure or prior to hospital discharge), target lesion revascularization (TLR), or stented segment restenosis (> 50%) at nine months postprocedure. | 9-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iliac, Artery, Occlusive, Stenosis