At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Trial Of Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention
In Brief
A clinical study evaluating Hybrid Coronary Revascularization (isolated LIMA-LAD), Hybrid Coronary Revascularization (PCI), and 1 other intervention for Coronary Artery Disease. Completed, enrolled 200 participants across 46 sites in 2 countries.
Detailed Summary
The purpose of the study is to learn which treatment option is better for patients who have multi-vessel coronary artery disease (blockages in more than one vessel supplying blood to the heart muscle). The treatment options this study will compare are: (1) Hybrid Coronary Revascularization \[HCR\] (a combination of surgery and catheter procedures to open up clogged heart arteries) and (2) Percutaneous Coronary Intervention \[PCI\] (catheter procedures alone to open up clogged heart arteries). There are no new or "experimental" procedures being tested in this study: both HCR and PCI are well-established procedures and are regularly performed in patients who have coronary artery disease. But, the FDA has not approved the drug-eluting stents used in PCI for all types of coronary artery disease. We have received an Investigational Device Exemption from the FDA to use the drug-eluting stents in this trial in the same way that they are used in clinical practice. The study being proposed here will use rigorous scientific methods and should result in a very high level of certainty about which procedure is best for patients with coronary artery disease.
Study Details
Timeline
Interventions
sternal-sparing, off-pump, isolated LIMA-LAD revascularization
percutaneous revascularization of at least one non-LAD target
Multi-vessel PCI with metallic drug-eluting stents (DES) including the LAD and or LM. Only FDA approved commercially available metallic drug-eluting stents may be used in this protocol.