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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid CABG/PCI | Experimental | Patients undergo hybrid, same sitting CABG/PCI as described. |
|
| Off-pump CABG | Other | Standard of Care Off Pump CABG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid CABG/PCI | Procedure | Same sitting hybrid, robotic CABG/PCI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Bachinsky, M.D. | Pinnacle Health Cardiovascular Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Pinnacle Harrisburg | Harrisburg | Pennsylvania | 17011 | United States |
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| Label | URL |
|---|---|
| Pinnacle Health Cardiovascular Institute | View source |
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| Off Pump CABG |
| Procedure |
Standard of Care Off Pump CABG |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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