Hybrid Coronary Revascularization Trial

Completed · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT03089398

Run by

Emilia Bagiella

People needed

200

Starts

2017-10-09

Expected to finish

2021-09-30

Last updated by the study team

2025-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation (US sites)
• Age ≥ 18 years
• Clinical indication for coronary revascularization
• Coronary anatomy requiring revascularization as follows(2)
• Multivessel CAD involving the LAD (proximal or mid) and/or LM (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 PCI Note: If the patient qualifies based only on a LM lesion, then there must be involvement of the distal bifurcation (Medina 1,1,1) intended for treatment with a 2-stent approach (separate stents into the LAD and LCX) if randomized to PCI. However, if the patient also has non-LM disease in the RCA and/or non-ostial LAD and/or non-ostial LCX that requires separate treatment, any LM lesion is a valid criterion for enrollment, whether LM ostial, shaft or distal bifurcation disease, and any strategy of treating the LM may be employed, including not treating the ostial LCX, a provisional approach or a planned 2-stent strategy as appropriate. Similarly, if the patient qualifies based only on LAD-Dg disease, whether a bifurcation lesion or separate lesions in the LAD and Dg, without RCA or LCX disease, then both the LAD and Dg must be true lesions intended for stents (planned 2-stent approach). However, if the patient has LAD-Dg disease and a lesion in the RCA or LCX that also requires treatment, the LAD-Dg disease can then be treated in any fashion (2-stents, a provisional approach, or the Dg not even dilated if it is small), according to operator preference
• Suitable candidate for both PCI with metallic DES and HCR as determined by clinical assessment and angiogram review by an interventional cardiologist and a cardiac surgeon at the enrolling clinical site
• 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

You may not qualify if…

• 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.
• Note: A patient may be considered eligible for enrollment if PCI with DES in non-LM and non-LAD territory was performed within 30 days prior to randomization, as long as revascularization was successful and uncomplicated, or has been performed more than 30 days prior even if unsuccessful or complicated
• Planned treatment with bioresorbable vascular scaffold(s) after randomization
• Total occlusion (TIMI 0 or 1 flow) of the LM, LAD or LCX.
• Cardiogenic shock at time of screening
• STEMI within 72 hours prior to randomization
• Need for concomitant vascular or other cardiac surgery during the index hospitalization (including, but not limited to, valve surgery, aortic resection, left ventricular aneurysmectomy, and carotid endarterectomy or stenting)
• Indication for chronic oral anticoagulation therapy at the time of randomization
• Any prior lung resection
• End-Stage Renal Disease (ESRD) on dialysis
• Patients who could not be switched from prasugrel or ticagrelor to clopidogrel, should that be needed prior to a CABG, during reverse HCR
• Extra-cardiac illness that is expected to limit survival to less than 5 years
• Allergy or hypersensitivity to any of the study drugs or devices used in the trial
• Therapy with an investigational drug, device or biologic within 1 year prior to randomization, or plan to enroll patient in additional investigational study during participation in this trial
• Unable to give informed consent or potential for noncompliance with the study protocol in the judgment of the investigator
• Pregnant at time of screening or unwilling to use effective birth control measures while dual antiplatelet therapy is required.

Where it is running

• Long Beach Memorial Medical Center — Long Beach, California, United States
• University of Southern California — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Stanford University — Stanford, California, United States
• Yale University — New Haven, Connecticut, United States
• HealthPark Lee Memorial Health Systems — Fort Myers, Florida, United States
• Orlando Health Heart Institute — Orlando, Florida, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Maryland — College Park, Maryland, United States
• Universty of Minnesota — Minneapolis, Minnesota, United States
• Our Lady of Lourdes Medical Center — Camden, New Jersey, United States
• Buffalo General Medical Center/Gates Vascular Institute — Buffalo, New York, United States
• Mount Sinai Beth Israel — New York, New York, United States
• Columbia University Medical Center/New York Presbyterian Hospital — New York, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• St. Joseph's Hospital Health Center — Syracuse, New York, United States
• Montefiore - Einstein — The Bronx, New York, United States
• Duke University — Durham, North Carolina, United States
• WakeMed Health and Hospitals — Raleigh, North Carolina, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• University of Toledo Medical Center — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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