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Comparison Between 2 Bilateral Internal Thoracic Artery Coronary Artery Bypass Grafting Configurations

NCT01666366 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2012-08-16

No results posted yet for this study

Summary

Bilateral internal thoracic arteries (BITA) demonstrated superiority over other grafts to the left coronary system in terms of patency and survival benefit. Several BITA configurations are proposed for left-sided myocardial revascularization, but the ideal BITA assemblage is still unidentified.

From 03/2003 to 08/2006, 1297 consecutive patients underwent isolated bypass surgery in our institution. 481 patients met the inclusion criteria for randomization and 304 (64%) were randomized. Patients were allocated to BITA in situ grafting (n=147) or Y configuration (n=152) then evaluated for clinical, functional, and angiographic outcome after 6 months, 3 and 7 years . Patient telephone interviews were conducted every 3 months and a stress test performed twice yearly under the referring cardiologist's supervision. Angiographic follow-up was performed 6 months after surgery. The primary and secondary end points were, respectively, major adverse cerebro-cardiovascular events (MACCE) and the proportion of ITA grafts that were completely occluded at follow-up angiography.

Conditions

  • Coronary Disease

Interventions

PROCEDURE

Coronary artery bypass grafting

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • David Glineur, MD PhD · Cliniques Universitaire St Luc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2006-08-31
Completion
2012-03-31

Countries

  • Belgium

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 NCT01666366 on ClinicalTrials.gov