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

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.

Study Overview

• Status: Completed
• Conditions: Arteriosclerosis of Coronary Artery Bypass Graft
• Intervention / Treatment: Procedure: Minimally invasive coronary artery bypass graft surgery

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y4W7
      • University of Ottawa Heart Institute
• United States
  • New York
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At time of procedure (day 1)
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.	At time of procedure (day 1)
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)	6 months post-procedure
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	During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Principal Investigator: Joseph McGinn, MD, Staten Island University Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

• Medtronic, Inc. Corporate Website

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: April 5, 2011
• First Submitted That Met QC Criteria: April 12, 2011
• First Posted (ESTIMATE): April 13, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 26, 2013
• Last Update Submitted That Met QC Criteria: November 3, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Coronary artery bypass grafting; Minimally invasive coronary surgery; MICS CABG
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Arteriosclerosis
• Other Study ID Numbers: D03782