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

Primary Purpose

Arteriosclerosis of Coronary Artery Bypass Graft

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Minimally invasive coronary artery bypass graft surgery
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arteriosclerosis of Coronary Artery Bypass Graft focused on measuring Minimally invasive coronary surgery, Coronary artery bypass grafting, MICS CABG

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Staten Island University Hospital
  • University of Ottawa Heart Institute

Outcomes

Primary Outcome Measures

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.
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.
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)
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

Secondary Outcome Measures

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

Full Information

First Posted
April 5, 2011
Last Updated
November 3, 2013
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT01334866
Brief Title
Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery
Acronym
MICS
Official Title
Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriosclerosis of Coronary Artery Bypass Graft
Keywords
Minimally invasive coronary surgery, Coronary artery bypass grafting, MICS CABG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Minimally invasive coronary artery bypass graft surgery
Other Intervention Name(s)
MICS CABG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Technical Success (Graft Patency) in a MICS Approach
Description
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)
Title
Procedural Success in a MICS Approach
Description
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)
Title
Patency of the Index Graft at 6 Months
Description
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
Title
Composite Major Adverse Event Rate (Early)
Description
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)
Secondary Outcome Measure Information:
Title
Composite Major Adverse Event Rate (Late)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph McGinn, MD
Organizational Affiliation
Staten Island University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4W7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24183338
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.
Results Reference
derived
Links:
URL
http://www.medtronic.com/
Description
Medtronic, Inc. Corporate Website

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

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