CompletedPhase 4

Study of Unprotected Left Main Stenting Versus Bypass Surgery (LE MANS Study)

United States, Poland130 participantsStarted 2001-01

Plain-language summary

Unprotected left main coronary artery (ULMCA) stenting, offering restoration of a native flow to left coronary artery, is the subject of intense investigations as a potential alternative to bypass surgery. The purpose of the study is to compare the short and long term results of unprotected left main stenting with coronary artery bypass surgery.

Who can participate

Age range

18 Years – 80 Years

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: * The patients' age 18 to 80 * Significant LM stenosis (\>50%) * The target vessel reference diameter 2.5mm. * Concomitant multivessel disease suitable for PCI is allowed. * The patient is an acceptable candidate for coronary artery bypass surgery. * The patient agreement for 6 month follow-up cardiac catheterization, which will include left ventricular angiogram. * The patient written informed consent. Exclusion Criteria: * An allergy or contraindication to aspirin, ticlopidine or Clopidogrel. * Presence of diffuse, significant (\>++) calcifications in LM * Left ventricular ejection fraction \< 35% * History of bleeding diathesis or coagulopathy. * Any previous PCI or CABG surgery * Acute MI within 48 hours, cardiogenic shock. * Bail-out stenting of dissected LM during complicated PCI. * The patient suffered a stroke or transient ischemic neurological attack (TIA) within 3 months. * Chronic renal insufficiency. * Positive pregnancy test. * Any disease that may shorten the life expectancy of the patient. * The patient is currently participating in another research study.

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

LV function assessed by 2D echocardiography

exercise tolerance measured with ECG treadmill stress testing

angina severity according to CCS classification 12 months after the index intervention

Trial details

NCT IDNCT00375063

SponsorMinistry of Science and Higher Education, Poland

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Coronary Artery Stenosis trials