Status:
ACTIVE_NOT_RECRUITING
PCI vs. CABG in the Treatment of Unprotected Left Main Stenosis
Lead Sponsor:
Evald Hoej Christiansen
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
Phase:
NA
Brief 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 co...
Detailed Description
Design: Randomised open multicentre trial. Patients: Number 1,200 Randomisation: PCI with DES vs CABG Individuals for inclusion will be recruited among the patients referred to the participating...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 6 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
1201 Patients enrolled
Trial Details
Trial ID
NCT01496651
Start Date
November 6 2008
End Date
December 31 2025
Last Update
May 1 2025
Active Locations (1)
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1
Aarhus University Hospital
Skejby, Aarhus N, Denmark, 8200