Status:
COMPLETED
Limus Eluted From A Durable Versus ERodable Stent Coating
Lead Sponsor:
Biosensors Europe SA
Conditions:
Coronary Disease
Coronary Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a non-inferiority trial.
Detailed Description
Compare the safety and efficacy of the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a prospective, multi-center, randomized, controlled,...
Eligibility Criteria
Inclusion
- Age \>= 18 years;
- Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction and ST-elevation myocardial infarction;
- Presence of one or more coronary artery stenoses \>50% in a native coronary artery or a saphenous bypass graft from 2.25 to 3.5 mm in diameter that can be covered with one or multiple stents;
- No limitation on the number of treated lesions, and vessels, and lesion length
Exclusion
- Pregnancy;
- Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Biolimus or contrast material;
- Inability to provide informed consent;
- Currently participating in another trial before reaching first endpoint;
- Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the perisurgical period
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
1707 Patients enrolled
Trial Details
Trial ID
NCT00389220
Start Date
November 1 2006
End Date
June 1 2012
Last Update
May 7 2019
Active Locations (10)
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1
Onze Lieve Vrouw Ziekenhuis, Cardiologisch Centrum, Moorselbaan 164
Aalst, Belgium, B-9300
2
L'Institut Cardiovasculaire Paris Sud, Institut Hospitalier Jacques Cartier, Service de Coronarographie, 6, Avenue du Noyer Lambert
Massy, France, 91300
3
Herzzentrum Leipzig, Innere Medizin/Kardiologie, Struimpellstrasse 39
Leipzig, Germany, D-04289
4
Universitatsklinikum Munchen, Medizinische Klinik Kardiologie, Ziemssenstrasse 1
Munich, Germany, 80336