Status:
UNKNOWN
Comparison of Biolimus A9 and Everolimus Drug-Eluting Stents in Patients With ST Segment Elevation Myocardial Infarction
Lead Sponsor:
Masaryk University
Conditions:
Coronary Heart Disease
Percutaneous Coronary Intervention
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is: * comparison of a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance...
Detailed Description
The aim of this multicenter, prospective, randomized trial with a core lab analysis is to assess the safety and effectiveness (at 9-month follow-up) of third generation DES (biolimus A9 and everolimus...
Eligibility Criteria
Inclusion
- Acute STEMI within 12 hours from symptoms onset
- Native coronary disease with a lesion suitable for stenting
- Vessel size in between 2.5-3.75mm
- Patient is willing to provide written informed consent
- Male or female patients between 18-85 years of age
Exclusion
- Significant left main disease
- Killip class IV
- Known allergy to aspirin and or clopidogrel/ticlopidine
- Recent bleeding (\<1month)
- Patient in anticoagulant therapy
- No suitable coronary anatomy for OCT scan (ostial lesion, very distal or large vessel /\>3.75mm in diameter/)
- Pregnancy
- Severe liver or renal disease (Cr\>2.0)
- Life expectancy \< 1 year
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00888758
Start Date
May 1 2009
End Date
May 1 2011
Last Update
May 1 2009
Active Locations (1)
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1
Department of Cardiology, Masaryk hospital and University of JEP
Ústí nad Labem, Czechia, 40113