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

January 17, 2017 updated by: C. R. Bard
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

134

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C. R. Bard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 20, 2007

First Posted (Estimate)

November 21, 2007

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BPV-1021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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