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

Phase 4

Completed

• Conditions: Arteriosclerosis of Coronary Artery Bypass Graft

• Registration Number: NCT01334866
• Lead Sponsor: Medtronic Cardiovascular

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2011-04-05
• Study First Submitted QC: 2011-04-12
• Study First Posted: 2011-04-13
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2013-08-09
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-03
• Last Update Submitted: 2013-11-03
• Results First Posted: 2013-11-26
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
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)
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.
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Staten Island University Hospital; 🇺🇸 Staten Island, New York, United States

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada