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

April 5, 2011
November 3, 2013
December 2009
April 2013   (final data collection date for primary outcome measure)
  • Technical Success (Graft Patency) in a MICS Approach [ Time Frame: At time of procedure (day 1) ] [ Designated as safety issue: No ]
    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 [ Time Frame: At time of procedure (day 1) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]

    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) [ Time Frame: During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation) ] [ Designated as safety issue: Yes ]

    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
  • Characterize technical success (graft patency) in a MICS approach [ Time Frame: At time of procedure (day 1) ] [ Designated as safety issue: No ]
    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.
  • Characterize procedural success in a MICS approach [ Time Frame: At time of procedure (day 1) ] [ Designated as safety issue: No ]
    A successful procedure can be defined as a procedures not requiring conversion (sternotomy).
  • Characterize patency of the index graft at 6 months [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]
    For each subject, the endpoint is the percent of stenosis collected on the subject's 6 month angiography form.
  • Characterize the composite major adverse event rate [ Time Frame: During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation) ] [ Designated as safety issue: Yes ]

    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
Complete list of historical versions of study NCT01334866 on ClinicalTrials.gov Archive Site
Composite Major Adverse Event Rate (Late) [ Time Frame: After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation ] [ Designated as safety issue: Yes ]

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
Demonstrate the composite major adverse event rate [ Time Frame: After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation ] [ Designated as safety issue: Yes ]

Demonstrate the composite major adverse event rate after 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation is comparable to historical control (literature). 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
Not Provided
Not Provided
 
Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery
Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Arteriosclerosis of Coronary Artery Bypass Graft
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.
Other Name: MICS CABG
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01334866
D03782
No
Medtronic Cardiovascular
Medtronic Cardiovascular
Not Provided
Principal Investigator: Joseph McGinn, MD Staten Island University Hospital
Medtronic Cardiovascular
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP