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Treatment of Moderate Vein Graft Lesions With Paclitaxel Drug Eluting Stents: The VELETI Trial

NCT00289835 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2011-11-24

No results posted yet for this study

Summary

HYPOTHESIS

1. Sealing moderate SVG lesions with the TAXUS stent prevents SVG atherosclerosis progression as evaluated by IVUS.
2. Sealing moderate SVG lesions with the TAXUS stent does not accelerate SVG atherosclerosis in the angiographically non-diseased segments of the SVG as evaluated by IVUS.

OBJECTIVES

1. To determine the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on limiting SVG disease progression as evaluated by IVUS.
2. To evaluate by IVUS the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on atherosclerosis progression in angiographically non-diseased SVGs segments.

Conditions

  • Coronary Artery Bypass Grafting

Interventions

DEVICE

Paclitaxel eluting stent

Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Laval University

    lead OTHER

Principal Investigators

  • Josep Rodes-Cabau, MD · Laval Hospital Research Center

  • Olivier F Bertrand, MD, PhD · Laval Hospital Research Center

  • Robert Delarocheliere, MD · Laval Hospital Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • Canada

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 NCT00289835 on ClinicalTrials.gov