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On Versus Off Pump Myocardial Revascularization Study

NCT01290952 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 411

Last updated 2016-11-21

Study results available
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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).

Conditions

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Medtronic Italia

    lead INDUSTRY

Principal Investigators

  • Massimo Lemma, Dr. · Ospedale Sacco-Milano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2010-06-30
Completion
2011-06-30

Countries

  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01290952 on ClinicalTrials.gov