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Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents

NCT01223443 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2016-10-27

No results posted yet for this study

Summary

Hypothesis: Sealing moderate SVG lesions with paclitaxel-eluting stents reduces cardiac events (death, myocardial infarction, target vessel revascularization) over the duration of follow-up.

Primary objective: To evaluate the efficacy of stenting moderate SVG lesions with paclitaxel-eluting stents on reducing the first occurrence of the composite of cardiac death, myocardial infarction or repeat revascularization related to the target SVG over the duration of follow-up (minimun of 2-year follow-up.

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

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    lead OTHER

Principal Investigators

  • Josep Rodes-Cabau, MD · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2015-08-31
Completion
2016-09-30

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 NCT01223443 on ClinicalTrials.gov