Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Arteriosclerosis of Coronary Artery Bypass Graft
- Sponsor
- Medtronic Cardiovascular
- Enrollment
- 91
- Locations
- 2
- Primary Endpoint
- Technical Success (Graft Patency) in a MICS Approach
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Technical Success (Graft Patency) in a MICS Approach
Time Frame: At time of procedure (day 1)
For each subject, the endpoint for technical success (graft patency) in a MICS approach is defined as acceptable flow for graft size for an anastamosis. This will be characterized by the surgeon's assessment/angiography after the graft is complete.
Patency of the Index Graft at 6 Months
Time Frame: 6 months post-procedure
For each subject, the endpoint is the percent of stenosis collected on the subject's 6 month angiography form. This will be characterized for each graft using the FitzGibbon scoring system based on the 64-Slice CT Angiography results. The FitzGibbon Scoring system is as follows: A:Excellent graft with unimpaired runoff (\< 50% stenosis) B:Stenosis reducing caliber of proximal or distal anastomoses or trunk to \<50% of the grafted coronary artery. O:Occluded (100% stenosed)
Procedural Success in a MICS Approach
Time Frame: At time of procedure (day 1)
A successful procedure can be defined as a procedures not requiring conversion (sternotomy). This will be characterized by whether the graft procedure can be completed through the minimally invasive thoracotomy without having to convert to a sternotomy in order to complete the grafting.
Composite Major Adverse Event Rate (Early)
Time Frame: During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation)
During procedure and within 30 days post-procedure or hospital discharge, whichever is longer. The adverse events will include: * Major hemorrhage/bleeding requiring surgical intervention * Aortic complications * Graft vessel revision (GVR) * Transient ischemic attacks (TIA) * Cerebrovascular accidents (CVA)/stroke * Myocardial infarction (MI) * Death
Secondary Outcomes
- Composite Major Adverse Event Rate (Late)(After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation)