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

NCT01334866 | Completed Phase 4 Results

• 1 other identifier: D03782
• Study Type: interventional
• Target: 91
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Arteriosclerosis of Coronary Artery Bypass Graft

Keywords

Minimally invasive coronary surgery; Coronary artery bypass grafting; MICS CABG

Outcome Measures

Primary Outcomes (4)

• Technical Success (Graft Patency) in a MICS Approach

  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.

  At time of procedure (day 1)

• Procedural Success in a MICS Approach

  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.

  At time of procedure (day 1)

• Patency of the Index Graft at 6 Months

  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)

  6 months post-procedure

• Composite Major Adverse Event Rate (Early)

  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

  During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation)

Secondary Outcomes (1)

• Composite Major Adverse Event Rate (Late)

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

Interventions

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.

Also known as: MICS CABG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (2)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

Related Publications (1)

• 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.

  PMID: 24183338 DERIVED

Related Links

• Medtronic, Inc. Corporate Website

Results Point of Contact

• Title: Kristin Lawman
• Organization: Medtronic, Inc.

kristin.j.lawman@medtronic.com

763-514-9809

Study Officials

• Joseph McGinn, MD

  Staten Island University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 13, 2011
• Study Start: December 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 26, 2013
• Results First Posted: November 26, 2013

Record last verified: 2013-11

Locations

US (1); CA (1)