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

Completed · Phase 4

Conditions studied: Coronary Artery Stenosis, Myocardial Revascularization, Myocardial Ischemia

In brief

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.

Key facts

Study ID

NCT00375063

Run by

Ministry of Science and Higher Education, Poland

People needed

130

Starts

2001-01-01

Expected to finish

2005-12-01

Last updated by the study team

2006-09-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sharpe-Strumia Research Foundation of the Bryn Mawr Hospital, Bryn Mawr, PA, USA and Thomas Jefferson University, Philadelphia — Bryn Mawr, Pennsylvania, United States
• San Antonio Endovascular and Heart Institute and University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• Jagiellonian University — Krakow, Lesser Poland Voivodeship, Poland
• Silesian Medical School 1-st Department of Cardiosurgery — Katowice, Silesian Voivodeship, Poland
• Silesian Medical School 3-rd Department of Cardiology, Coronary Care Unit — Katowice, Silesian Voivodeship, Poland

Full record on ClinicalTrials.gov

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