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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Medtronic Italia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medtronic Italia
ClinicalTrials.gov Identifier:
NCT01290952
First received: February 4, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Coronary Artery Disease
Procedure: Off-pump bypass surgery
Procedure: On-pump bypass surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ON Pump vs OFF Pump Myocardial Revascularization in High Risk Patients: a Randomized Study

Resource links provided by NLM:


Further study details as provided by Medtronic Italia:

Primary Outcome Measures:
  • post-operative combined endpoint [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Operative Mortality Myocardial Infarction Postoperative neurologicalal complications Renal failure ARDS Bleeding


Secondary Outcome Measures:
  • secondary combined endpoint [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Post-operative Atrial Fibrillation IAPB insertion and low cardiac output syndrome Ventilation > 24h Sternal wound infection or dehiscence Length of stay in the intensive care unit Hospital length of stay One year Mortality One year MACE One year ischemic evidence


Enrollment: 630
Study Start Date: September 2006
Estimated Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Off pump
Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
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.
Active Comparator: On-pump
coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290952

Locations
Italy
Policlinico
Bari, Italy
S. Anna e S. Sebastiano
Caserta, Italy
Ospedale Luigi Sacco
Milano, Italy, 20100
European Hospital
Roma, Italy
Ospedale S. Camillo
Roma, Italy
Ospedale S. Giovanni di Dio e Ruggi d'Aragona
Salerno, Italy
Ospedale Molinette
Torino, Italy
Switzerland
University Hospital
Zurich, Switzerland
Sponsors and Collaborators
Medtronic Italia
Investigators
Principal Investigator: Massimo Lemma, Dr. Ospedale Sacco-Milano
  More Information

Publications:

Responsible Party: AGNESE ROSSI, MEDTRONIC ITALIA SPA
ClinicalTrials.gov Identifier: NCT01290952     History of Changes
Other Study ID Numbers: 030211
Study First Received: February 4, 2011
Last Updated: February 4, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Medtronic Italia:
off-pump
bypass
coronary artery surgery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014