Evaluation of Outcomes of EES Implantation for Unprotected Left Main Coronary Artery Stenosis (PR… (NCT01348022) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Outcomes of EES Implantation for Unprotected Left Main Coronary Artery Stenosis (PRE-COMBAT 2)
South Korea397 participantsStarted 2009-08
Plain-language summary
This study is a multicenter, open label, prospective, single arm trial
Single arm group; following angiography, eligible patients with unprotected LMCA stenosis \>50% by visual estimation, which is equally treatable by the both treatment strategy (EES stenting or CABG), will be treated with EES
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient must be at least 18 years of age.
✓. Significant de novo left main stenosis (\>50% by visual estimation) with or without any additional target lesions (\>70% by visual estimation)
✓. Left main lesion and lesions outside LMCA (if present) potentially equally treatable with coronary stenting and CABG
✓. Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia
✓. The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion criteria
✕. The patient has a known hypersensitivity or contraindication to any of the following medications:
✕. Systemic (intravenous) Everolimus, paclitaxel or ABT-578 use within 12 months.
✕. Any previous PCI within 1 year
✕. Previous bypass surgery
✕. Any previous PCI of a LMCA or ostial left circumflex artery or ostial left anterior descending artery lesion within 1 year
✕. Intention to treat more than one totally occluded major epicardial vessel