Phase 4
Completed N=91
Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery
Arteriosclerosis of Coronary Artery Bypass Graft
Source: ClinicalTrials.gov NCT01334866 ↗
Enrolled (actual)
91
Serious AEs
15.7%
Results posted
Nov 2013
Primary outcomePrimary: Technical Success (Graft Patency) in a MICS Approach — 100 percentage of grafts
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Technical Success (Graft Patency) in a MICS Approach |
100 | — |
| PRIMARY Procedural Success in a MICS Approach |
100 | — |
| PRIMARY Patency of the Index Graft at 6 Months |
90.9; 0.6; 8.5 | — |
| PRIMARY Composite Major Adverse Event Rate (Early) |
2.2 | — |
| SECONDARY Composite Major Adverse Event Rate (Late) |
— | — |
Eligibility Criteria
Inclusion Criteria
- > or equal to 18 and 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
Data sourced from ClinicalTrials.gov (NCT01334866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.