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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

This study is currently recruiting participants.
Verified March 2016 by Pinnacle Health Cardiovascular Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT00928356
First Posted: June 25, 2009
Last Update Posted: April 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pinnacle Health Cardiovascular Institute
June 23, 2009
June 25, 2009
April 4, 2016
September 2008
December 2017   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00928356 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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
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
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.

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
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Artery Disease
  • Procedure: Hybrid CABG/PCI
    Same sitting hybrid, robotic CABG/PCI
  • Procedure: Off Pump CABG
    Standard of Care Off Pump CABG
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
March 2018
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact: William Bachinsky, MD 7177310101 ext 3002 wbachinsky@pinnaclehealth.org
Contact: Anita Todd, RN 7177310101 ext 3002 atodd@pinnaclehealth.org
United States
 
 
NCT00928356
Same Sitting Robotic CABG/PCI
Yes
Not Provided
Plan to Share IPD: Undecided
Pinnacle Health Cardiovascular Institute
Pinnacle Health Cardiovascular Institute
Not Provided
Principal Investigator: William Bachinsky, M.D. Pinnacle Health Cardiovascular Institute, Inc.
Pinnacle Health Cardiovascular Institute
March 2016

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