ClinicalTrials.Veeva

Menu

On Versus Off Pump Myocardial Revascularization Study (On-Off)

Medtronic logo

Medtronic

Status and phase

Completed
Phase 4

Conditions

Coronary Artery Disease

Treatments

Procedure: On-pump bypass surgery
Procedure: Off-pump bypass surgery

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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).

Full description

The initial application of off-pump coronary artery bypass in the early nineties was mainly directed to highly selected and relatively low risk surgical patients. Since then there has been a growing body of evidence suggesting many potential advantages of the OPCAB technique over the conventional cardiopulmonary bypass (CPB) technique in different groups of high-risk patients.

On-off study is a multicentre, prospective, randomized, parallel, trial.Patients indicated for elective or urgent isolated coronary artery bypass graft with additive European System for Cardiac Operative Risk Evaluation ≥ 6 were enrolled. Patients in cardiogenic shock were excluded. Patients were randomly assigned either to coronary artery bypass surgery with cardiopulmonary bypass (ON arm) or to off-pump coronary artery bypass graft (OFF arm). The composite primary end point included operative mortality, myocardial infarction, stroke, renal failure, re-operation for bleeding and adult respiratory distress syndrome, within 30 days after surgery. The total planned sample size was 693 patients; the actual number of enrolled patients was 411,according to the results of the interim analysis scheduled at 400 enrollments (alfa-spending=0.029, Pocock method).

Enrollment

411 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

411 participants in 2 patient groups

Off-pump bypass surgery
Experimental group
Description:
Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
Treatment:
Procedure: Off-pump bypass surgery
On-pump bypass surgery
Active Comparator group
Description:
coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
Treatment:
Procedure: On-pump bypass surgery

Trial contacts and locations

8

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems