EXCEL Clinical Trial

Inclusion Criteria:

* Inclusion criteria for RCT:

- Unprotected left main coronary artery (ULMCA) disease with angiographic diameter
stenosis (DS) ≥70% requiring revascularization, or

- ULMCA disease with agniographic DS >=50% but < 70% requiring revascularization, with
one or more of the following present:

- Non-invasive evidence of ischemia referable to a hemodynamically significant left
main lesion (large area of ischemia in both the LAD and LCX territories, or in
either the LAD or LCX territory in the absence of other obstructive coronary
artery disease to explain the LAD or LCX defect), or stress-induced hypotension
or stress-induced fall in LVEF, or stress-induced transient ischemic dilatation
of the left ventricle or stress-induced thallium/technetiumlung uptake, and/or

- IVUS minimum lumen area (MLA) <= 6.0mm2, and/or

- Fractional Flow Reserve (FFR) <=0.80

- Left Main Equivalent Disease

- Clinical and anatomic eligibility for both PCI and CABG

- Silent ischemia, stable angina, unstable angina or recent MI

- Ability to sign informed consent and comply with all study procedures including
follow-up for at least three years

Exclusion Criteria:

* Clinical exclusion criteria:

- Prior PCI of the left main trunk at any time prior to randomization

- Prior PCI of any other coronary artery lesions within one year prior to randomization

- Prior CABG at any time prior to randomization

- Need for any concomitant cardiac surgery other than CABG, or intent that if the
subject randomizes to surgery, any cardiac surgical procedure other than isolated CABG
will be performed

- CK-MB greater than the local laboratory upper limit of normal or recent MI with CK-MB
still elevated

- Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for at
least one year

- Subjects requiring or who may require additional surgery within one year

- The presence of any clinical condition(s) which leads the participating interventional
cardiologist to believe that clinical equipoise is not present

- The presence of any clinical condition(s) which leads the participating cardiac
surgeon to believe that clinical equipoise is not present

- Pregnancy or intention to become pregnant

- Non cardiac co-morbidities with life expectancy less than 3 years

- Other investigational drug or device studies that have not reached their primary
endpoint

- Vulnerable population who in the judgment of the investigator is unable to give
Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances
or lack of autonomy. This may include: Individuals with mental disability, persons in
nursing homes, children, impoverished persons, persons in emergency situations,
homeless persons, nomads, refugees, and those permanently incapable of giving informed
consent. Vulnerable populations also may include members of a group with a
hierarchical structure such as university students, subordinate hospital and
laboratory personnel, employees of the Sponsor, members of the armed forces, and
persons kept in detention

Angiographic exclusion criteria:

- Left main diameter stenosis <50%

- SYNTAX score ≥33

- Left main reference vessel diameter <2.25 mm or >4.25 mm

- The presence of specific coronary lesion characteristics or other cardiac condition(s)
which leads the participating interventional cardiologist to believe that clinical
equipoise is not present

- The presence of specific coronary lesion characteristics or other cardiac condition(s)
which leads the participating cardiac surgeon to believe that clinical equipoise is
not present