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

This study has been completed.
Sponsor:
Information provided by:
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00561457
First received: November 20, 2007
Last updated: April 6, 2011
Last verified: April 2011

November 20, 2007
April 6, 2011
June 2003
January 2008   (final data collection date for primary outcome measure)
Rate of Major Adverse Clinical Events (MACE) [ Time Frame: 9-months ] [ Designated as safety issue: Yes ]
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.
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. [ Time Frame: hospital discharge to nine months ]
Complete list of historical versions of study NCT00561457 on ClinicalTrials.gov Archive Site
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A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System
A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System

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

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.

Interventional
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Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Iliac Artery Occlusive Disease
Device: Bard Luminexx Iliac Stent and Delivery System
Iliac Stenting
Other Name: Bard Luminexx Iliac Stent and Delivery System
Experimental: Iliac Stenting
Stent placement in the iliac artery
Intervention: Device: Bard Luminexx Iliac Stent and Delivery System
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
134
January 2008
January 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00561457
BPV-1021
No
John Reviere, Director of Clinical Affairs, Bard Peripheral Vascular
C. R. Bard
Not Provided
Not Provided
C. R. Bard
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP