At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 411 enrolled

Drug / intervention

Off-pump bypass surgery +1 moreprocedure

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01290952

NCT01290952Phase 4Completed

Compare CT.gov

ON Pump vs OFF Pump Myocardial Revascularization in High Risk Patients: a Randomized Study

Medtronic Italia·interventional·Posted Feb 7, 2011·Updated Nov 21, 2016

In Brief

A Phase 4 clinical trial evaluating Off-pump bypass surgery and On-pump bypass surgery for Coronary Artery Disease. Completed, enrolled 411 participants across 8 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCoronary Artery Disease

CountriesItaly, Switzerland

Collaborators--

Timeline

Phase 4CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartSep 2006

Primary CompletionJun 2010

First PostedFeb 2011

Study CompletionJun 2011

TodayJul 2026

First PostedFeb 7, 2011

Enrollment StartSep 1, 2006

Primary CompletionJun 1, 2010

Study CompletionJun 1, 2011

TodayJul 2, 2026

Enrollment to primary: 3.8 yearsPosted 15.4 years ago

Interventions

Off-pump bypass surgeryprocedure

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.

On-pump bypass surgeryprocedure

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.