PCI vs. CABG in the Treatment of Unprotected Left Main Stenosis (NCT01496651) | Clinical Trial Compass
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
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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).