Clinical trial NCT01334866: Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery
Official title: Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arteriosclerosis of Coronary Artery Bypass Graft
Keywords: Minimally invasive coronary surgery
Coronary artery bypass grafting
MICS CABG
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2011-04-13
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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
* Severe distal disease and small posterior lateral targets

Primary outcomes:
measure: Technical Success (Graft Patency) in a MICS Approach
timeFrame: At time of procedure (day 1)
measure: Procedural Success in a MICS Approach
timeFrame: At time of procedure (day 1)
measure: Patency of the Index Graft at 6 Months
timeFrame: 6 months post-procedure
measure: Composite Major Adverse Event Rate (Early)
timeFrame: During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation)
Secondary outcomes:
measure: Composite Major Adverse Event Rate (Late)
timeFrame: After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Staten Island University Hospital
name: Joseph McGinn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruel M, Shariff MA, Lapierre H, Goyal N, Dennie C, Sadel SM, Sohmer B, McGinn JT Jr. Results of the Minimally Invasive Coronary Artery Bypass Grafting Angiographic Patency Study. J Thorac Cardiovasc Surg. 2014 Jan;147(1):203-8. doi: 10.1016/j.jtcvs.2013.09.016. Epub 2013 Oct 30.