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

NCT ID: NCT01334866

Last Updated: 2013-11-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Arteriosclerosis of Coronary Artery Bypass Graft

Keywords

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Minimally invasive coronary surgery Coronary artery bypass grafting MICS CABG

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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MICS CABG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiovascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph McGinn, MD

Role: PRINCIPAL_INVESTIGATOR

Staten Island University Hospital

Locations

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Staten Island University Hospital

Staten Island, New York, United States

Site Status

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 24183338 (View on PubMed)

Related Links

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http://www.medtronic.com/

Medtronic, Inc. Corporate Website

Other Identifiers

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D03782

Identifier Type: -

Identifier Source: org_study_id