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
  Purpose

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.


Condition Intervention Phase
Arteriosclerosis of Coronary Artery Bypass Graft
Procedure: Minimally invasive coronary artery bypass graft surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 91
Study Start Date: December 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334866

Locations
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W7
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Principal Investigator: Joseph McGinn, MD Staten Island University Hospital
  More Information

Additional Information:
No publications provided by Medtronic Cardiovascular

Additional 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

Keywords provided by Medtronic Cardiovascular:
Minimally invasive coronary surgery
Coronary artery bypass grafting
MICS CABG

Additional relevant MeSH terms:
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014