Status:
COMPLETED
Study of Unprotected Left Main Stenting Versus Bypass Surgery (LE MANS Study)
Lead Sponsor:
Ministry of Science and Higher Education, Poland
Conditions:
Coronary Artery Stenosis
Myocardial Revascularization
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 sur...
Detailed Description
The natural history and the results of pharmacological treatment in patients with severe narrowing of left main coronary artery show very poor prognosis (5 year survival less than 50%). There is gene...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00375063
Start Date
January 1 2001
End Date
December 1 2005
Last Update
September 12 2006
Active Locations (5)
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1
Sharpe-Strumia Research Foundation of the Bryn Mawr Hospital, Bryn Mawr, PA, USA and Thomas Jefferson University, Philadelphia
Bryn Mawr, Pennsylvania, United States, 19010
2
San Antonio Endovascular and Heart Institute and University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78248
3
Jagiellonian University
Krakow, Lesser Poland Voivodeship, Poland, 31-147
4
Silesian Medical School 1-st Department of Cardiosurgery
Katowice, Silesian Voivodeship, Poland, 40-635