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

• Sponsor: Pinnacle Health Cardiovascular Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00928356
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Arms: 2
• Actual Duration (Months): 129.9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Procedure: Hybrid CABG/PCI; Procedure: Off Pump CABG	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 14, 2008
• Actual Primary Completion Date: May 19, 2015
• Actual Study Completion Date: Aug 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hybrid CABG/PCI Patients undergo hybrid, same sitting CABG/PCI as described.	Procedure: Hybrid CABG/PCI; Same sitting hybrid, robotic CABG/PCI
Other: Off-pump CABG Standard of Care Off Pump CABG	Procedure: Off Pump CABG; Standard of Care Off Pump CABG

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UPMC Pinnacle Harrisburg	Harrisburg	Pennsylvania	United States	17011

Sponsors and Collaborators

• Pinnacle Health Cardiovascular Institute

Investigators

• Principal Investigator: William Bachinsky, M.D., Pinnacle Health Cardiovascular Institute, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Pinnacle Health Cardiovascular Institute

Publications

None provided.

• Responsible Party: Pinnacle Health Cardiovascular Institute
• ClinicalTrials.gov Identifier: NCT00928356
• Other Study ID Numbers: Same Sitting Robotic CABG/PCI
• First Posted: Jun 25, 2009
• Last Update Posted: May 11, 2020
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pinnacle Health Cardiovascular Institute: Coronary Artery Disease; Robotic Coronary Artery Bypass Surgery; Percutaneous Coronary Intervention; Hybrid Coronary Revascularization
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

No Results Posted as of May 11, 2020