Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery

Completed · Phase 4

Conditions studied: Arteriosclerosis of Coronary Artery Bypass Graft

In brief

This clinical study has been developed to evaluate the clinical outcomes in patients undergoing coronary artery bypass grafting via Minimally Invasive Coronary Surgery (MICS); a minimally invasive coronary bypass procedure that is done on a beating heart via a smaller chest incision, thus avoiding the invasiveness of the standard procedure.

Key facts

Study ID

NCT01334866

Run by

Medtronic Cardiovascular

People needed

91

Starts

2009-12-01

Expected to finish

2013-04-01

Last updated by the study team

2013-11-26

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > or equal to 18 and < or equal to 80 years of age
• Suitable minimally invasive coronary surgery (MICS) candidate for non-emergent first time, single or multivessel coronary artery bypass grafting (on pump or off pump)
• Left ventricle ejection fraction >30%
• Willing and able to provide written informed consent and comply with study requirements

You may not qualify if…

• Severe cerebrovascular disease within 90 days of surgery including history of prior stroke.
• Previous cardiac surgery procedures such as CABG revisions, surgical ablations or valve replacements
• Congestive heart failure with a New York Heart Association (NYHA) Class IV
• History of renal insufficiency (i.e. prior serum creatinine of >2mg/dl) and/or requiring dialysis
• Uncontrolled diabetes (i.e. >2 serum glucose concentrations of >350 mg/dl)
• Severe uncontrolled systemic hypertension (i.e. systolic pressure >160 mmHg)
• Peripheral/systemic active infection excluding the patient from cardiac surgery
• Life expectancy of less than 1 year due to other illness such as cancer or pulmonary, hepatic or renal disease
• Participation in another investigational protocol that may confound the results of this study
• Female of child bearing potential and lactating or intends to become pregnant during the study
• Severe distal disease and small posterior lateral targets

Where it is running

• Staten Island University Hospital — Staten Island, New York, United States
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.