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The Study to Treat Superficial Femoral Artery Occlusions.

NCT00232843 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2009-06-03

No results posted yet for this study

Summary

The main objective of this study is to assess the performance of the Cordis SMART™ nitinol self-expandable stent for the treatment of superficial femoral artery (SFA) occlusions in comparison with balloon angioplasty only as determined by binary restenosis at one year.

Conditions

  • Arterial Occlusive Diseases

Interventions

DEVICE

stent

Cordis SMART™ nitinol self-expanding stent.

DEVICE

angioplasty

balloon angioplasty

Sponsors & Collaborators

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • Nick Chalmers, MD · Manchester Royal Infirmary

  • Mark Cowling, MD · University Hospital of North Staffordshire

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2009-04-30
Completion
2009-05-31

Countries

  • United Kingdom

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 NCT00232843 on ClinicalTrials.gov