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The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent

NCT00235131 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2010-02-04

No results posted yet for this study

Summary

This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System for the treatment of TASC C \& D superficial femoral artery long lesions (up to 22 cm) in comparison with the Bard® Luminexx™ 6F Vascular Stent as determined by the primary patency rate at 6 and 12 months post procedure.

Conditions

  • Arterial Occlusive Diseases

Interventions

DEVICE

Smart Stent

Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System

DEVICE

Luminexx Stent

Bard® Luminexx™ 6F Vascular Stent

Sponsors & Collaborators

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • Dierk Schneinert, MD · Heart Center Leipzig - University Hospital

  • Stephan Duda, MD · Gemeinschaftspraxis füsar Radiologische

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2008-03-31
Completion
2009-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00235131 on ClinicalTrials.gov