Hybrid Coronary Revascularization Trial

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.

Conditions

• Coronary Artery Disease

Interventions

PROCEDURE

Hybrid Coronary Revascularization (isolated LIMA-LAD)

sternal-sparing, off-pump, isolated LIMA-LAD revascularization

DEVICE

Hybrid Coronary Revascularization (PCI)

percutaneous revascularization of at least one non-LAD target

DEVICE

Percutaneous Coronary Intervention

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Emilia Bagiella

  lead OTHER

Principal Investigators

• Emilia Bagiella, PhD · Icahn School of Medicine at Mount Sinai

• Alan Moskowitz, MD · Ichan School of Medicine at Mount Sinai

• John Puskas, MD · Icahn School of Medicine at Mount Sinai

• Gregg Stone, MD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-09

Primary Completion

2021-03-31

Completion

2021-09-30

FDA Device

Yes

Countries

• United States
• Canada

Study Locations