To establish the safety and efficacy of the commercially approved XIENCE Family Stent System (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO \[for use outside the United States \[OUS\] only\]) in subjects with unprotected left main coronary artery disease by comparing to coronary artery bypass graft surgery.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
What they're measuring
1
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke