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A Clinical Investigation of SM-01 Stenting Versus PTA for the Treatment of Superficial Femoral Artery Disease

NCT01183117 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2015-04-02

No results posted yet for this study

Summary

The main objective is to evaluate the safety and efficacy of SM-01 stenting (Cordis S.M.A.R.T.™ Nitinol Stent System) for the treatment of SFA lesions as compared to PTA (balloon angioplasty). If SM-01 is used in a PTA-bailout patient, the case will be assessed separately.

Conditions

  • Peripheral Vascular Diseases

Interventions

DEVICE

SM-01

SM-01 is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.

DEVICE

PTA

balloon angioplasty

Sponsors & Collaborators

  • Johnson & Johnson K.K. Medical Company

    lead INDUSTRY

Principal Investigators

  • Hidehiko Hara, MD · Toho University Ohashi Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-09-30
Completion
2014-08-31

Countries

  • Japan

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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 NCT01183117 on ClinicalTrials.gov