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
NCT ID: NCT00928356
Last Updated: 2020-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2008-10-14
2019-08-13
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hybrid CABG/PCI
Patients undergo hybrid, same sitting CABG/PCI as described.
Hybrid CABG/PCI
Same sitting hybrid, robotic CABG/PCI
Off-pump CABG
Standard of Care Off Pump CABG
Off Pump CABG
Standard of Care Off Pump CABG
Interventions
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Hybrid CABG/PCI
Same sitting hybrid, robotic CABG/PCI
Off Pump CABG
Standard of Care Off Pump CABG
Eligibility Criteria
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Inclusion Criteria
* Anatomy and body habitus suitable for Robotic CABG
* Requirement of revascularization of arteries amendable for PCI but not accessable by Robotic CABG
Exclusion Criteria
ALL
No
Sponsors
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Pinnacle Health Cardiovascular Institute
NETWORK
Responsible Party
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Principal Investigators
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William Bachinsky, M.D.
Role: PRINCIPAL_INVESTIGATOR
Pinnacle Health Cardiovascular Institute, Inc.
Locations
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UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, United States
Countries
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Related Links
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Pinnacle Health Cardiovascular Institute
Other Identifiers
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Same Sitting Robotic CABG/PCI
Identifier Type: -
Identifier Source: org_study_id
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