Phase 4
N=411
On Versus Off Pump Myocardial Revascularization Study
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01290952 ↗Enrolled (actual)
411
Serious AEs
11.2%
Results posted
Nov 2016
Primary outcome: Primary: Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following) — 13; 26 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Off-pump bypass surgery (Procedure); On-pump bypass surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Italia
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following) |
13; 26 | — |
| SECONDARY Number of Patients With Secondary Combined Endpoint (i.e. With One or More of the Following) |
73; 67 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01290952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.