A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System - Full Text View

Sponsored by:	C. R. Bard
Information provided by:	C. R. Bard
ClinicalTrials.gov Identifier:	NCT00561457

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
Common and/or External Iliac Artery Occlusive Disease	Device: Bard Luminexx Iliac Stent and Delivery System

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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:

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 ]

Enrollment:	134
Study Start Date:	June 2003
Study Completion Date:	October 2007

Arms	Assigned Interventions
1: Experimental Iliac stenting	Device: Bard Luminexx Iliac Stent and Delivery System Iliac Stenting

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

No Contacts or Locations Provided

More Information

Study ID Numbers:	BPV-1021
Study First Received:	November 20, 2007
Last Updated:	November 20, 2007
ClinicalTrials.gov Identifier:	NCT00561457
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on January 15, 2009