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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 20, 2007
Last Updated Date	April 6, 2011
Start Date ^ICMJE	June 2003
Primary Completion Date	January 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 6, 2011)	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.
Original Primary Outcome Measures ^ICMJE (submitted: November 20, 2007)	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 ]
Change History	Complete list of historical versions of study NCT00561457 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System
Official Title ^ICMJE	A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System
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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Iliac Artery Occlusive Disease
Intervention ^ICMJE	Device: Bard Luminexx Iliac Stent and Delivery System Iliac Stenting Other Name: Bard Luminexx Iliac Stent and Delivery System
Study Arm (s)	Experimental: Iliac Stenting Stent placement in the iliac artery Intervention: Device: Bard Luminexx Iliac Stent and Delivery System
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	134
Completion Date	January 2008
Primary Completion Date	January 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00561457
Other Study ID Numbers ^ICMJE	BPV-1021
Has Data Monitoring Committee	No
Responsible Party	John Reviere, Director of Clinical Affairs, Bard Peripheral Vascular
Study Sponsor ^ICMJE	C. R. Bard
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	C. R. Bard
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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