Sternal Cerclage (sternal bone closure after open heart surgery)

  • sponsor
    Heart Lung and Blood Institute
Updated on 5 February 2021
acute coronary syndrome
coronary revascularization


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. Patients randomized to Hybrid therapy will undergo robotic midcab + drug eluting stent/stents at our facilities.


Condition Coronary Artery Disease, Coronary Artery Disease, Heart Attack (Myocardial Infarction) Heart Disease Myocardial Ischemia Open Heart Surgery
Clinical Study IdentifierTX133848
SponsorHeart Lung and Blood Institute
Last Modified on5 February 2021


Yes No Not Sure

Inclusion Criteria

•Signed informed consent, inclusive of release of medical information, and
Health Insurance Portability and Accountability Act (HIPAA) documentation (US
•Age ≥ 18 years
•Clinical indication for coronary revascularization that will be determined by
both a surgeon and an interventional cardiologist together
(Coronary anatomy requiring revascularization will be discussed with you
during your visit with cardiology to determine eligibility.)
◦Multivessel Coronary Artery Disease (CAD) involving the Left Anterior
Descending (LAD) (proximal or mid) and/or Left Main (ostial, mid-shaft or
distal) with at least 1 other epicardial coronary artery requiring treatment
(LCX or RCA), OR
◦Single vessel disease involving the LAD and a major diagonal, with both
requiring independent revascularization with at least one stent if randomized
to HCR and stents for both the LAD and diagonal if randomized to multivessel
Note: Other inclusions apply as determined by clinical evaluation and
angiogram imaging
•Ability to tolerate and no plans to interrupt dual anti-platelet therapy for
≥ 6 months if presentation with stable CAD, or ≥ 12 months if presentation
with biomarker positive acute coronary syndrome (ACS)
•Willing to comply with all protocol required follow-up

Exclusion Criteria

•Previous cardiac surgery of any kind, including CABG
•Previous thoracic surgery involving the left pleural space
•Previous LM or LAD stent (a) with evidence of in-stent restenosis or (b)
within 1 cm of a qualifying lesion
•Previous PCI of the LM and/or LAD within 12 months prior to randomization
•PCI with bare metal stent (BMS) within 12 months prior to randomization
•Any complication or unsuccessful revascularization with PCI within 30 days
prior to randomization
Other Details
Participating in a study is a personal decision. Discuss with your family
members and doctor before deciding to join a study. You or your doctor may
contact the study research staff to learn more about this study
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