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

Not Applicable

Completed

• Conditions: Iliac Artery Occlusive Disease
• Interventions: Device: Bard Luminexx Iliac Stent and Delivery System

• Registration Number: NCT00561457
• Lead Sponsor: C. R. Bard

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-20
• Study First Posted: 2007-11-21
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-05-26
• Results First Submitted QC: 2011-04-06
• Results First Posted: 2011-05-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iliac Stenting	Bard Luminexx Iliac Stent and Delivery System	Stent placement in the iliac artery

Primary Outcome Measures

Name	Time	Method
Rate of Major Adverse Clinical Events (MACE)	9-months	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.