The Catholic University BIMA Grafting Study
NCT01593865 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000
Last updated 2012-08-21
Summary
The present study hypothesizes that the systematic use of bilateral internal mammary artery (BIMA) grafting is feasible in the practice of a University Cardiac Surgery Institution for the treatment of multivessel coronary artery disease (primary hypothesis). The secondary study hypothesis is that the BIMA grafting meets the safety endpoint compared with the conventional surgical strategy entailing left mammary artery grafting plus great saphenous vein grafts to revascularize the remaining coronary targets. The tertiary study hypothesis is that the BIMA grafting yields better follow-up results in terms of recurrence of symptoms related to coronary disease, of repeat revascularization and of cardiac mortality compared with patients treated with the conventional surgical strategy entailing left mammary artery grafting plus great saphenous vein grafts to revascularize the remaining coronary targets.
Conditions
- Multivessel Coronary Artery Disease
Interventions
- PROCEDURE
-
BIMA Grafting
Both the left and the right internal mammary arteries are harvested and used to revascularize the two major coronary targets. Further coronary targets may be revascularized using either great saphenous vein or radial artery grafts, if present.
- PROCEDURE
-
Left-only mammary artery grafting
These patients had only the left mammary artery harvested and used to revascularize the major coronary target. Great saphenous vein grafts and/or radial artery grafts were employed to revascularize the remaining targets.
Sponsors & Collaborators
-
Catholic University, Italy
lead OTHER
Principal Investigators
-
Massimo Massetti, MD · Division of Cardiac Surgery, Catholic University
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-04-30
- Primary Completion
- 2014-06-30
Countries
- Italy
Study Locations
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