Status:
COMPLETED
SEA-SIDE: Sirolimus Versus Everolimus-eluting Stent Randomized Assessment in Bifurcated Lesions and Clinical SIgnificance of Residual siDE-branch Stenosis
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Coronary Artery Disease
Coronary Stenosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
BACKGROUND: Bifurcated lesions are a challenging subset in percutaneous coronary interventions (PCI). The selection of the type of DES and the technique for stent implantation have not been clarified...
Detailed Description
Bifurcated lesions are challenging target lesions in percutaneous coronary interventions (PCI) which may specifically benefit from the usage of drug-eluting stents (DES). However, the selection of the...
Eligibility Criteria
Inclusion
- de novo bifurcated lesions
- lesions \>50% located in a major bifurcation point
- TIMI \>2 on both main vessel and side branch
- main vessel visual diameter \>2.5 mm
- side branch visual diameter \>2.0 mm
- \>18 years of age
- signed the informed consent to enter the study
Exclusion
- known hypersensitivity to Sirolimus, Everolimus, cobalt, chromium, nickel, tungsten acrylic and fluoro-polymers
- contraindications to double antiplatelet therapy acute (within 48 hours) ST-elevation acute myocardial infarction
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00697372
Start Date
September 1 2007
End Date
April 1 2010
Last Update
June 15 2010
Active Locations (1)
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1
Institute of Cardiology - Catholic University of Sacred Heart
Rome, Italy, 00168