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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 91 subjects were enrolled, with 89 subjects receiving the study treatment. The first subject was enrolled on December 30, 2009 and the last subject was enrolled on October 4, 2012. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Minimally Invasive Coronary Artery Bypass Grafting	91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.

Participant Flow:   Overall Study

	Minimally Invasive Coronary Artery Bypass Grafting
STARTED	91 [1]
COMPLETED	72
NOT COMPLETED	19
Withdrawal by Subject	10
Lost to Follow-up	3
Physician Decision	3
medically necessary prior to procedure	2
medically necessary post-procedure	1

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Study Completion Cohort	91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.

Baseline Measures

	Study Completion Cohort
Overall Participants Analyzed  [Units: Participants]	91
Age  [Units: Years] Mean (Standard Deviation)	64.1  (8.3)
Gender  [Units: Participants]
Female	10
Male	81
Region of Enrollment  [Units: Participants]
United States	45
Canada	46

1.  Primary:

Technical Success (Graft Patency) in a MICS Approach   [ Time Frame: At time of procedure (day 1) ]

2.  Primary:

Procedural Success in a MICS Approach   [ Time Frame: At time of procedure (day 1) ]

3.  Primary:

Patency of the Index Graft at 6 Months   [ Time Frame: 6 months post-procedure ]

4.  Primary:

Composite Major Adverse Event Rate (Early)   [ Time Frame: During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation) ]

5.  Secondary:

Composite Major Adverse Event Rate (Late)   [ Time Frame: After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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