Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments off-pump bypass surgery, on-pump bypass surgery
Phase phase 4
Sponsor Medtronic Italia
Start date September 2006
End date June 2010
Trial size 630 participants
Trial identifier NCT01290952, 030211

Summary

Compare completeness and modality of revascularization, operative and postoperative results and 1 year clinical outcomes in unselected high risk patients referred for primary coronary artery bypass surgery. Patients will be randomized to undergo off-pump coronary artery bypass graft (OPCAB) or coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
off-pump bypass surgery
is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally.
(Active Comparator)
coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
on-pump bypass surgery
is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.

Primary Outcomes

Measure
post-operative combined endpoint
time frame: 30 days

Secondary Outcomes

Measure
secondary combined endpoint
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Pts candidate to a myocardial revascularization for any patter of coronary artery disease, ventricular dysfunction or any other co-morbidity - EUROSCORE ≥ 6 - Pts who signed the Informed Consent - Age ≥ 18 years Exclusion Criteria: - Patients in cardiogenic shock requiring emergency surgery or preoperative intra-aortic balloon pump - Patients requiring additional surgical procedures - Porcelain Aorta - Lack of informed consent

Additional Information

Official title ON Pump vs OFF Pump Myocardial Revascularization in High Risk Patients: a Randomized Study
Principal investigator Massimo Lemma, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in February 2011.
Information provided to ClinicalTrials.gov by Medtronic Italia.