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OpenTrials
Completed

NCT Number: NCT01334866

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.

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Key information

Conditions

Arteriosclerosis of Coronary Artery Bypass Graft

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Ottawa Heart Institute, Ottawa, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimally invasive coronary artery bypass graft surgery

Procedure

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 names: MICS CABG

Primary outcomes

  1. Technical Success (Graft Patency) in a MICS Approach

    Time frame: At time of procedure (day 1)

    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.

  2. Procedural Success in a MICS Approach

    Time frame: At time of procedure (day 1)

    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.

  3. Patency of the Index Graft at 6 Months

    Time frame: 6 months post-procedure

    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)

  4. 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)

    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 outcomes

  1. Composite Major Adverse Event Rate (Late)

    Time frame: After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation

    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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiovascular

Industry

Registry information

Acronym: MICS

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Apr 13, 2011
Registry last updated
Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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