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
1 other identifier
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Oct 2008
Longer than P75 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2008
CompletedFirst Submitted
Initial submission to the registry
June 23, 2009
CompletedFirst Posted
Study publicly available on registry
June 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2019
CompletedMay 11, 2020
March 1, 2019
6.6 years
June 23, 2009
May 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
1 year
Secondary Outcomes (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.
1 year
Study Arms (2)
Hybrid CABG/PCI
EXPERIMENTALPatients undergo hybrid, same sitting CABG/PCI as described.
Off-pump CABG
OTHERStandard of Care Off Pump CABG
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Need for emergent CABG
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, 17011, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Bachinsky, M.D.
Pinnacle Health Cardiovascular Institute, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2009
First Posted
June 25, 2009
Study Start
October 14, 2008
Primary Completion
May 19, 2015
Study Completion
August 13, 2019
Last Updated
May 11, 2020
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share