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

Arteriosclerosis of Coronary Artery Bypass Graft Clinical Trial

— MICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334866
• Other study ID #: D03782
• Status: Completed
• Phase: Phase 4
• First received: April 5, 2011
• Last updated: November 3, 2013
• Start date: December 2009
• Est. completion date: April 2013

Study information

• Verified date: November 2013
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Arteriosclerosis of Coronary Artery Bypass Graft

Intervention

Procedure:
• Minimally invasive coronary artery bypass graft surgery
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.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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	No
Primary	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)	Yes
Secondary	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	Yes

External Links

•   Medtronic, Inc. Corporate Website