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The SOS (Stenting Of Saphenous Vein Grafts) Trial

NCT00247208 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2012-04-26

No results posted yet for this study

Summary

The main purpose of this study is to determine whether implantation of a paclitaxel-eluting stent (Taxus™) in saphenous vein graft lesions will reduce the incidence of in-stent restenosis after 12 months when compared to a similar bare metal stent.

Conditions

  • Coronary Artery Bypass
  • Arteriosclerosis

Interventions

DEVICE

Taxus polymer-based paclitaxel-eluting stent

Two different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions.

DEVICE

Express 2 bare metal stent

Two different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions.

Sponsors & Collaborators

  • Clark R. Gregg Fund, Harris Methodist Foundation

    collaborator UNKNOWN

  • University of Arkansas

    collaborator OTHER

  • US Department of Veterans Affairs

    collaborator FED

  • Michael E. DeBakey VA Medical Center

    collaborator FED

  • Southern Arizona VA Health Care System

    collaborator FED

  • Onassis Cardiac Surgery Centre

    collaborator OTHER

  • North Texas Veterans Healthcare System

    lead FED

Principal Investigators

  • Emmanouil S Brilakis, MD, PhD · VA North Texas Health Care System, University of Texas Southwestern Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2008-10-31
Completion
2011-06-30

Countries

  • United States
  • Greece

Study Locations

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Entities

Companies

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 NCT00247208 on ClinicalTrials.gov