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
  Purpose

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 Intervention
Iliac Artery Occlusive Disease
Device: Bard Luminexx Iliac Stent and Delivery System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System

Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • 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.


Enrollment: 134
Study Start Date: June 2003
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iliac Stenting
Stent placement in the iliac artery
Device: Bard Luminexx Iliac Stent and Delivery System
Iliac Stenting
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: John Reviere, Director of Clinical Affairs, Bard Peripheral Vascular
ClinicalTrials.gov Identifier: NCT00561457     History of Changes
Other Study ID Numbers: BPV-1021
Study First Received: November 20, 2007
Results First Received: May 26, 2009
Last Updated: April 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by C. R. Bard:
Iliac
Artery
Occlusive
Stenosis

ClinicalTrials.gov processed this record on September 22, 2014