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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Successful completion of same sitting CABG and coronary stent procedure Successful completion of CABG and PCI during single hospitalization Achievement of complete revascularization 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. Stent thrombosis at 24 hours (acute), 30 days (sub acute), and 1 year (late) One-year composite clinical event endpoints of major clinical events including death, repeat revascularization, myocardial infarction, and freedom from angina 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

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Hybrid CABG/PCI
* Procedure: Off Pump CABG


Participation Criteria
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Eligibility Criteria
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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
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid CABG/PCI<br>Patients undergo hybrid, same sitting CABG/PCI as described. | Procedure: Hybrid CABG/PCI<br>* Same sitting hybrid, robotic CABG/PCI<br>|
| Other: Off-pump CABG<br>Standard of Care Off Pump CABG | Procedure: Off Pump CABG<br>* Standard of Care Off Pump CABG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Robotic Coronary Artery Bypass Surgery, Percutaneous Coronary Intervention, Hybrid Coronary Revascularization