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. (see Contacts and Locations)
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
  Purpose

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 Intervention
Coronary Artery Disease
Procedure: Hybrid CABG/PCI
Procedure: Off Pump CABG

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pinnacle Health Cardiovascular Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 350
Study Start Date: September 2008
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Pinnacle Health Cardiovascular Institute
ClinicalTrials.gov Identifier: NCT00928356     History of Changes
Other Study ID Numbers: Same Sitting Robotic CABG/PCI
Study First Received: June 23, 2009
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014