Active — Not RecruitingNot Applicable

PCI vs. CABG in the Treatment of Unprotected Left Main Stenosis

Denmark1,201 participantsStarted 2008-11-06

Plain-language summary

Coronary Artery Bypass Grafting Versus Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis. In a clinical, randomized, 5-year follow-up study to compare essential clinical outcome parameters in patients with unprotected left main (LMCA) disease, treated with coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) using drug eluting stents (DES). DES-PCI of unprotected LMCA disease is non-inferior to CABG concerning the 2-year rate of death, myocardial infarction, stroke or new revascularization and concerning the 5-year rate of death.

Who can participate

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: * Stable, unstable angina pectoris or ACS. * Significant lesion\* of LMCA ostium, mid-shaft and/or bifurcation and with no more than three additional non-complex\*\* PCI lesions. * Patient eligible to be treated by CABG and by PCI * Signed informed consent. \*Visually assessed diameter stenosis \>50% or fractional flow reserve \<0.80. \*\*Length \<25 mm, non-CTO, non-2-stent bifurcation, non-calcified and non-tortuous vessel morphology coronary lesion. Exclusion Criteria: * ST-elevation infarction within 24 hours. * CABG clearly better treatment option (LMCA stenosis and \>3, or complex\*\* additional coronary lesions) * Patient is in too high risk for CABG. * Expected survival \<1 year. * Allergy to aspirin, clopidogrel or ticlopidine. * Allergy to Biolimus. \*\*Length \>25 mm, CTO, 2-stent bifurcation, calcified or tortuous vessel morphology coronary lesion.

What they're measuring

Combined endpoint of death, stroke, non-index treatment related MI and new revascularization (PCI or CABG)

Timeframe: From date of first randomisation until a total number of 275 events is reached (or max 5 years).

Trial details

NCT IDNCT01496651

SponsorEvald Hoej Christiansen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-01-22

View on ClinicalTrials.gov More Coronary Artery Disease trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.