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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

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ClinicalTrials.gov Identifier: NCT00928356
Recruitment Status : Recruiting
First Posted : June 25, 2009
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Coronary Artery Disease Procedure: Hybrid CABG/PCI Procedure: Off Pump CABG

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2008
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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
Off-pump CABG
Standard of Care Off Pump CABG
Procedure: Off Pump CABG
Standard of Care Off Pump CABG


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928356


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

Locations
United States, Pennsylvania
Pinnacle Health @ Harrisburg Hospital Recruiting
Harrisburg, Pennsylvania, United States, 17011
Contact: Anita Todd, RN    717-731-0101 ext 3002    atodd@pinnaclehealth.org   
Principal Investigator: William Bachinsky, MD         
Sponsors and Collaborators
Pinnacle Health Cardiovascular Institute
Investigators
Principal Investigator: William Bachinsky, M.D. Pinnacle Health Cardiovascular Institute, Inc.
More Information

Additional Information:
Responsible Party: Pinnacle Health Cardiovascular Institute
ClinicalTrials.gov Identifier: NCT00928356     History of Changes
Other Study ID Numbers: Same Sitting Robotic CABG/PCI
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Pinnacle Health Cardiovascular Institute:
Coronary Artery Disease
Robotic Coronary Artery Bypass Surgery
Percutaneous Coronary Intervention
Hybrid Coronary Revascularization

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases