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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01334866
First received: April 5, 2011
Last updated: November 3, 2013
Last verified: November 2013
History of Changes
Results First Received: August 9, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Arteriosclerosis of Coronary Artery Bypass Graft
Intervention: Procedure: Minimally invasive coronary artery bypass graft surgery

  Participant Flow
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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  
[1] 91 subjects were enrolled in the study; with 89 subjects receiving the study treatment.



  Baseline Characteristics
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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  
Number of Participants  
[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  



  Outcome Measures
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1.  Primary:   Technical Success (Graft Patency) in a MICS Approach   [ Time Frame: At time of procedure (day 1) ]
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2.  Primary:   Procedural Success in a MICS Approach   [ Time Frame: At time of procedure (day 1) ]
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3.  Primary:   Patency of the Index Graft at 6 Months   [ Time Frame: 6 months post-procedure ]
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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) ]
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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 ]
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  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kristin Lawman
Organization: Medtronic, Inc.
phone: 763-514-9809
e-mail: kristin.j.lawman@medtronic.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01334866     History of Changes
Other Study ID Numbers: D03782
Study First Received: April 5, 2011
Results First Received: August 9, 2013
Last Updated: November 3, 2013
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee