Arteriosclerosis of Coronary Artery Bypass Graft
Conditions
Keywords
Minimally invasive coronary surgery, Coronary artery bypass grafting, MICS CABG
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.
Interventions
PROCEDUREMinimally invasive coronary artery bypass graft surgery
The MICS CABG procedure can bridge the gap between percutaneous coronary intervention (PCI) and standard sternotomy. The key components are direct vision, creating anastomoses with traditional instruments and proximal aortic location.
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success (Graft Patency) in a MICS Approach | 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. |
| Procedural Success in a MICS Approach | 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. |
| Patency of the Index Graft at 6 Months | 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) |
| Composite Major Adverse Event Rate (Early) | 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
| Measure | Time frame | Description |
|---|---|---|
| Composite Major Adverse Event Rate (Late) | After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation | Characterize the composite major adverse event rate after 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation. The major 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 |
Countries
Canada, United States
Participant flow
Recruitment details
A total of 91 subjects were enrolled, with 89 subjects receiving the study treatment. The first subject was enrolled on December 30, 2009 and the last subject was enrolled on October 4, 2012. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
Participants by arm
| Arm | Count |
|---|---|
| Study Completion Cohort 91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit. | 91 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | medically necessary post-procedure | 1 |
| Overall Study | medically necessary prior to procedure | 2 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Study Completion Cohort |
|---|---|
| Age Continuous | 64.1 years STANDARD_DEVIATION 8.3 |
| Region of Enrollment Canada | 46 participants |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 46 / 89 |
| serious Total, serious adverse events | 14 / 89 |
Outcome results
Primary
Composite Major Adverse Event Rate (Early)
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
Time frame: During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Minimally Invasive Coronary Artery Bypass Grafting | Composite Major Adverse Event Rate (Early) | 2.2 percentage of subjects |
Primary
Patency of the Index Graft at 6 Months
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)
Time frame: 6 months post-procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Minimally Invasive Coronary Artery Bypass Grafting | Patency of the Index Graft at 6 Months | Grade A | 90.9 percentage of grafts |
| Minimally Invasive Coronary Artery Bypass Grafting | Patency of the Index Graft at 6 Months | Grade B | 0.6 percentage of grafts |
| Minimally Invasive Coronary Artery Bypass Grafting | Patency of the Index Graft at 6 Months | Grade O | 8.5 percentage of grafts |
Primary
Procedural Success in a MICS Approach
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.
Time frame: At time of procedure (day 1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Minimally Invasive Coronary Artery Bypass Grafting | Procedural Success in a MICS Approach | 100 percentage of subjects |
Primary
Technical Success (Graft Patency) in a MICS Approach
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.
Time frame: At time of procedure (day 1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Minimally Invasive Coronary Artery Bypass Grafting | Technical Success (Graft Patency) in a MICS Approach | 100 percentage of grafts |
Secondary
Composite Major Adverse Event Rate (Late)
Characterize the composite major adverse event rate after 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation. The major 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
Time frame: After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Minimally Invasive Coronary Artery Bypass Grafting | Composite Major Adverse Event Rate (Late) | 0 percentage of subjects |