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

May 7, 2020 updated by: Pinnacle Health Cardiovascular Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. Successful completion of same sitting CABG and coronary stent procedure
  2. Successful completion of CABG and PCI during single hospitalization
  3. Achievement of complete revascularization
  4. 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.
  5. Stent thrombosis at 24 hours (acute), 30 days (sub acute), and 1 year (late)
  6. One-year composite clinical event endpoints of major clinical events including death, repeat revascularization, myocardial infarction, and freedom from angina
  7. 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

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17011
        • UPMC Pinnacle Harrisburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hybrid CABG/PCI
Patients undergo hybrid, same sitting CABG/PCI as described.
Procedure: Hybrid CABG/PCI
Same sitting hybrid, robotic CABG/PCI
Other: Off-pump CABG
Standard of Care Off Pump CABG
Procedure: Off Pump CABG
Standard of Care Off Pump CABG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pinnacle Health Cardiovascular Institute

Investigators

  • Principal Investigator: William Bachinsky, M.D., Pinnacle Health Cardiovascular Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2008

Primary Completion (Actual)

May 19, 2015

Study Completion (Actual)

August 13, 2019

Study Registration Dates

First Submitted

June 23, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (Estimate)

June 25, 2009

Study Record Updates

Last Update Posted (Actual)

May 11, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Same Sitting Robotic CABG/PCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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