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The Study to Compare SMART Nitinol Stent and Balloon Angioplasty

NCT00309595 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-06-12

No results posted yet for this study

Summary

This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ Nitinol Stent System compared to balloon angioplasty. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study.

Objective of the study is: Performance of the Cordis S.M.A.R.T.™ (CONTROL™) Nitinol Stent System for the treatment of superficial femoral artery (SFA) long de novo or restenotic lesions (≥ 70% stenosis or occlusions) in comparison with balloon angioplasty as determined by Binary Restenosis (≥50% restenosis based on a peak systolic velocity ratio ≥ 2.5) at one year as demonstrated by Duplex sonography.

Conditions

  • Superficial Femoral Artery Occlusions

Interventions

DEVICE

stent

Cordis SMART™ Nitinol Stent System

DEVICE

balloon

balloon angioplasty

Sponsors & Collaborators

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • Iris Baumgartner, MD · Leitende Aerztin & Leiterin Vaskuläre Forschung - University Hospital Bern

  • Beatrice Amann, MD · Leitende Ärztin Angiologie - University Hospital Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Switzerland

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 NCT00309595 on ClinicalTrials.gov