Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2016-08-31
2018-07-27
Brief Summary
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Detailed Description
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This study will collect information about the medical care participants receive during their planned procedure. No new testing or procedures will be done. Participants will have only the tests or procedures already planned by their doctor. The investigators will look at how well participants do after the procedure by assessing the outcomes of interest 30 days after surgery and, potentially, one year after surgery (funding dependent).
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Hybrid Coronary Revascularization (HCR)
Patients who are scheduled to have the hybrid coronary revascularization (HCR) procedure for treatment of multi-vessel coronary artery disease. The treatment plan is determined by the patient's doctor.
Hybrid Coronary Revascularization (HCR)
Hybrid coronary revascularization (HCR) is a combination of surgery and catheter procedures to open up clogged heart arteries. HCR is the intentional combination of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI). The HCR strategy combines grafting of the left anterior descending artery (LAD) coronary artery using the left internal mammary artery (LIMA) with PCI of non-LAD coronary stenoses. Drug-eluting stents are substituted for saphenous vein grafts (SVG) for non-LAD coronary targets, and the surgical LIMA to LAD bypass is performed, ideally through a minimally invasive, limited access, sternal-sparing approach.
Coronary Artery Bypass Grafting (CABG)
Patients who are scheduled to have the coronary artery bypass grafting (CABG) procedure for treatment of multi-vessel coronary artery disease. The treatment plan is determined by the patient's doctor.
Coronary Artery Bypass Grafting (CABG)
Coronary artery bypass grafting (CABG) is a surgery to create a new path for blood flow to the heart. A healthy section of vein or artery from elsewhere in the patient's body will be attached to the coronary artery just above and below the area of concern, to create a way for blood to bypass the blocked part of the coronary artery.
Interventions
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Hybrid Coronary Revascularization (HCR)
Hybrid coronary revascularization (HCR) is a combination of surgery and catheter procedures to open up clogged heart arteries. HCR is the intentional combination of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI). The HCR strategy combines grafting of the left anterior descending artery (LAD) coronary artery using the left internal mammary artery (LIMA) with PCI of non-LAD coronary stenoses. Drug-eluting stents are substituted for saphenous vein grafts (SVG) for non-LAD coronary targets, and the surgical LIMA to LAD bypass is performed, ideally through a minimally invasive, limited access, sternal-sparing approach.
Coronary Artery Bypass Grafting (CABG)
Coronary artery bypass grafting (CABG) is a surgery to create a new path for blood flow to the heart. A healthy section of vein or artery from elsewhere in the patient's body will be attached to the coronary artery just above and below the area of concern, to create a way for blood to bypass the blocked part of the coronary artery.
Eligibility Criteria
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Inclusion Criteria
* Have multi-vessel coronary artery disease (CAD) involving the Left Anterior Descending (LAD) artery
* Have a clinical indication for revascularization
* Are a candidate for either HCR or CABG or both
* Anatomy suitable for HCR shall include
1. Multi-vessel CAD involving the LAD and/or
2. LAD disease and involvement of a major diagonal artery, both of which require revascularization
Exclusion Criteria
* Severe left ventricular dysfunction with ejection fraction (EF) \< 30%
* Patients with chest radiation
* Body mass index (BMI) \> 35
* Severe peripheral vascular disease (PVD)
* Acute ischemia requiring emergent traditional coronary artery bypass graft (CABG)
ALL
No
Sponsors
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Emory University
OTHER
Responsible Party
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Michael Halkos
Associate Professor of Surgery
Principal Investigators
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Michael Halkos, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University Hospital Midtown
Atlanta, Georgia, United States
Countries
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Other Identifiers
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IRB00089868
Identifier Type: -
Identifier Source: org_study_id
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