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

Covidien

Status and phase: Completed; Phase 4

Conditions: Arteriosclerosis of Coronary Artery Bypass Graft

Treatments: Procedure: Minimally invasive coronary artery bypass graft surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT01334866

D03782

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)