NCT01593865

The Catholic University BIMA Grafting Study

Observational, Case-Control, Propensity-Matched Study of Bilateral Versus Monolateral Internal Mammary Artery Grafting for Severe Coronary Artery Disease. Assessment of Feasibility of Systematic Bilateral Mammary Artery Grafting and Early/Late Clinical Outcomes

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Catholic University, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-06-01
• First posted: 2012-05-08
• Last updated: 2012-08-21

Locations

1 site across 1 country: Italy