Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Pinnacle Harrisburg

Harrisburg, Pennsylvania, 17011, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hybrid CABG/PCI

Procedure

Same sitting hybrid, robotic CABG/PCI

Off Pump CABG

Procedure

Standard of Care Off Pump CABG

Primary outcomes

  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.

    Time frame: 1 year

Secondary outcomes

  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.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Pinnacle Health Cardiovascular Institute

Network

Registry information

Important dates

Study start
2008
Primary completion
2015
Study completion
2019
First posted
Jun 25, 2009
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.