NCT00928356

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Pinnacle Health Cardiovascular Institute · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Hybrid CABG/PCI	Same sitting hybrid, robotic CABG/PCI
PROCEDURE	Off Pump CABG	Standard of Care Off Pump CABG

Timeline

• Start date: 2008-10-14
• Primary completion: 2015-05-19
• Completion: 2019-08-13
• First posted: 2009-06-25
• Last updated: 2020-05-11

Locations

1 site across 1 country: United States