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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00561457
Recruitment Status : Completed
First Posted : November 21, 2007
Results First Posted : May 4, 2011
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Iliac Artery Occlusive Disease Device: Bard Luminexx Iliac Stent and Delivery System

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System
Study Start Date : June 2003
Primary Completion Date : January 2008
Study Completion Date : January 2008

Arm Intervention/treatment
Experimental: Iliac Stenting
Stent placement in the iliac artery
Device: Bard Luminexx Iliac Stent and Delivery System
Iliac Stenting

Primary Outcome Measures :
  1. Rate of Major Adverse Clinical Events (MACE) [ Time Frame: 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00561457     History of Changes
Other Study ID Numbers: BPV-1021
First Posted: November 21, 2007    Key Record Dates
Results First Posted: May 4, 2011
Last Update Posted: March 1, 2017
Last Verified: January 2017

Keywords provided by C. R. Bard: