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

Pinnacle Health Cardiovascular Institute

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: Off Pump CABG; Procedure: Hybrid CABG/PCI

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00928356

Same Sitting Robotic CABG/PCI

Details and patient eligibility

About

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.

Full 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

Enrollment: 88 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Hybrid CABG/PCI

Experimental group

Description:

Patients undergo hybrid, same sitting CABG/PCI as described.

Treatment:

Procedure: Hybrid CABG/PCI

Off-pump CABG

Other group

Description:

Standard of Care Off Pump CABG

Treatment:

Procedure: Off Pump CABG