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
This study is currently recruiting participants.
Verified May 2013 by Pinnacle Health Cardiovascular Institute
Sponsor:
Pinnacle Health Cardiovascular Institute
Information provided by (Responsible Party):
Pinnacle Health Cardiovascular Institute
ClinicalTrials.gov Identifier:
NCT00928356
First received: June 23, 2009
Last updated: May 2, 2013
Last verified: May 2013
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Purpose
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 | Intervention |
|---|---|
|
Coronary Artery Disease |
Procedure: Hybrid CABG/PCI Procedure: Off Pump CABG |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Pinnacle Health Cardiovascular Institute:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 350 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Hybrid CABG/PCI
Patients undergo hybrid, same sitting CABG/PCI as described.
|
Procedure: Hybrid CABG/PCI
Same sitting hybrid, robotic CABG/PCI
|
|
Off-pump CABG
Standard of Care Off Pump CABG
|
Procedure: Off Pump CABG
Standard of Care Off Pump CABG
|
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:
- 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
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928356
Contacts
| Contact: William Bachinsky, MD | 7177310101 ext 3002 | wbachinsky@pinnaclehealth.org |
| Contact: Anita Todd, RN | 7177310101 ext 3002 | atodd@pinnaclehealth.org |
Locations
| United States, Pennsylvania | |
| Pinnacle Health @ Harrisburg Hospital | Recruiting |
| Harrisburg, Pennsylvania, United States, 17011 | |
| Contact: Anita Todd, RN 717-731-0101 ext 3002 atodd@pinnaclehealth.org | |
| Principal Investigator: William Bachinsky, MD | |
Sponsors and Collaborators
Pinnacle Health Cardiovascular Institute
Investigators
| Principal Investigator: | William Bachinsky, M.D. | Pinnacle Health Cardiovascular Institute, Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pinnacle Health Cardiovascular Institute |
| ClinicalTrials.gov Identifier: | NCT00928356 History of Changes |
| Other Study ID Numbers: | Same Sitting Robotic CABG/PCI |
| Study First Received: | June 23, 2009 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
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 Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013