Sternal Cerclage (sternal bone closure after open heart surgery)
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- STATUS
- Recruiting
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- sponsor
- Heart Lung and Blood Institute
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).
Description
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. Patients randomized to Hybrid therapy will undergo robotic midcab + drug eluting stent/stents at our facilities.
Details
| Condition | Coronary Artery Disease, Coronary Artery Disease, Heart Attack (Myocardial Infarction) Heart Disease Myocardial Ischemia Open Heart Surgery |
|---|---|
| Clinical Study Identifier | TX133848 |
| Sponsor | Heart Lung and Blood Institute |
| Last Modified on | 5 February 2021 |
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