A Single Center Clinical Evaluation of Same Sitting Hybrid Revascularization: Robotic Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention for the Treatment of Coronary Artery Disease

This study is currently recruiting participants.

Verified May 2013 by Pinnacle Health Cardiovascular Institute

Sponsor:

Information provided by (Responsible Party):

Pinnacle Health Cardiovascular Institute

ClinicalTrials.gov Identifier:

NCT00928356

First received: June 23, 2009

Last updated: May 2, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 23, 2009

Last Updated Date

May 2, 2013

Start Date ^ICMJE

September 2008

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary endpoint of this feasibility study is a 30-day composite of major adverse clinical events including death, repeat revascularization, stroke and/or myocardial infarction. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00928356 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

One-year composite clinical event endpoints of major clinical events. Comparative analysis of consecutive patients undergoing off pump CABG with standard thoracotomy during study period. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Single Center Clinical Evaluation of Same Sitting Hybrid Revascularization: Robotic Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention for the Treatment of Coronary Artery Disease

Official Title ^ICMJE

Brief Summary

The primary objective of this study is to assess the safety and effectiveness of same sitting, simultaneous hybrid robotic assisted coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in the treatment of obstructive multivessel coronary artery disease. A secondary objective is the assessment and standardization of optimal operator techniques and comparative study of patients undergoing CABG during study period.

Detailed Description

The study population will consist of patients with multivessel coronary artery disease requiring CABG with suitable anatomy for combination CABG and PCI of non-bypassed arteries.

The primary endpoint of this feasibility study is a 30-day composite of major adverse clinical events including death, repeat revascularization, stroke and/or myocardial infarction.

The secondary endpoints include:

Successful completion of same sitting CABG and coronary stent procedure
Successful completion of CABG and PCI during single hospitalization
Achievement of complete revascularization
Patency of the LIMA and stented vessels as determined by coronary angiography at time of procedures or prior to discharge and by cardiac Computed Tomographic Angiography (CTA) or coronary angiography at 1 year.
Stent thrombosis at 24 hours (acute), 30 days (sub acute), and 1 year (late)
One-year composite clinical event endpoints of major clinical events including death, repeat revascularization, myocardial infarction, and freedom from angina
Comparative analysis of hospital, 30 day, and 1 year events of hybrid CABG patients compared to consecutive patients undergoing off pump CABG with standard thoracotomy during study period

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Procedure: Hybrid CABG/PCI
Same sitting hybrid, robotic CABG/PCI
Procedure: Off Pump CABG
Standard of Care Off Pump CABG

Study Arm (s)

Experimental: Hybrid CABG/PCI
Patients undergo hybrid, same sitting CABG/PCI as described.

Intervention: Procedure: Hybrid CABG/PCI
Off-pump CABG
Standard of Care Off Pump CABG

Intervention: Procedure: Off Pump CABG

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

350

Estimated Completion Date

March 2015

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Requirement for CABG
Anatomy and body habitus suitable for Robotic CABG
Requirement of revascularization of arteries amendable for PCI but not accessable by Robotic CABG

Exclusion Criteria:

Need for emergent CABG

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: William Bachinsky, MD	7177310101 ext 3002	wbachinsky@pinnaclehealth.org
Contact: Anita Todd, RN	7177310101 ext 3002	atodd@pinnaclehealth.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00928356

Other Study ID Numbers ^ICMJE

Same Sitting Robotic CABG/PCI

Has Data Monitoring Committee

Yes

Responsible Party

Pinnacle Health Cardiovascular Institute

Study Sponsor ^ICMJE

Pinnacle Health Cardiovascular Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

William Bachinsky, M.D.

Pinnacle Health Cardiovascular Institute, Inc.

Information Provided By

Pinnacle Health Cardiovascular Institute

Verification Date

May 2013

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

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