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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928356
• Other study ID #: Same Sitting Robotic CABG/PCI
• Status: Completed
• Phase: N/A
• Start date: October 14, 2008
• Est. completion date: August 13, 2019

Study information

• Verified date: March 2019
• Source: Pinnacle Health Cardiovascular Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 13, 2019
• Est. primary completion date: May 19, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Hybrid CABG/PCI
Same sitting hybrid, robotic CABG/PCI
• Off Pump CABG
Standard of Care Off Pump CABG

Locations

Country	Name	City	State
United States	UPMC Pinnacle Harrisburg	Harrisburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pinnacle Health Cardiovascular Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Pinnacle Health Cardiovascular Institute