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.
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, non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,707
Coronary stent placement
Onze Lieve Vrouw Ziekenhuis, Cardiologisch Centrum, Moorselbaan 164
Aalst, Belgium
L'Institut Cardiovasculaire Paris Sud, Institut Hospitalier Jacques Cartier, Service de Coronarographie, 6, Avenue du Noyer Lambert
Massy, France
Herzzentrum Leipzig, Innere Medizin/Kardiologie, Struimpellstrasse 39
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
Time frame: 9 month
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
Time frame: 30 days
Cardiac death
Cardiac death
Time frame: 30 days
All deaths
All deaths (cardiac and non-cardiac)
Time frame: 30 days
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Time frame: 30 days
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Time frame: 30 days
In-stent and in-segment binary restenosis rate as assessed by QCA.
In-stent and in-segment binary restenosis rate as assessed by QCA.
Time frame: 9 month
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Leipzig, Germany
Universitatsklinikum Munchen, Medizinische Klinik Kardiologie, Ziemssenstrasse 1
Munich, Germany
Klinikum Bogenhausen der Stad München, Abteilung für Kardiologie und Pnemlogie, Englschalkstrasse 77
Munich, Germany
University Medical Center Rotterdam Erasmus, Thoraxcentrum
Rotterdam, Netherlands
American Heart of Poland Sp. z o.o.
Dąbrowa Górnicza, Poland
Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern, Inselspital
Bern, Switzerland
University Hospital Zürich, Director of Invasive Cardiology, Rämistrasse 100
Zurich, Switzerland
Royal Brompton Hospital, Sydney Street
London, United Kingdom
In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA.
In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA
Time frame: 9 month
In-segment percent diameter stenosis (%DS).
In-segment percent diameter stenosis (%DS) as assessed by QCA
Time frame: 9 month
In-stent and in-segment late luminal loss
In-stent and in-segment late luminal loss as assessed by QCA
Time frame: 9 month
Device success, lesion success and procedural success.
Time frame: at implant
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
Time frame: 6 month
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
Time frame: 1 year
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
Time frame: 2 years
Cardiac death
Cardiac death
Time frame: 6 month
Cardiac death
Cardiac death
Time frame: 9 month
Cardiac death
Cardiac death
Time frame: 1 year
Cardiac death
Cardiac death
Time frame: 2 year
Cardiac death
Cardiac death
Time frame: 3 year
Cardiac death
Cardiac death
Time frame: 4 year
Cardiac death
Cardiac death
Time frame: 5 year
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
Time frame: 3 year
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
Time frame: 4 year
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
Time frame: 5 year
All deaths
All deaths (cardiac and non-cardiac)
Time frame: 6 month
All deaths
All deaths (cardiac and non-cardiac)
Time frame: 9 month
All deaths
All deaths (cardiac and non-cardiac)
Time frame: 1 year
All deaths
All deaths (cardiac and non-cardiac)
Time frame: 2 years
All deaths
All deaths (cardiac and non-cardiac)
Time frame: 3 years
All deaths
All deaths (cardiac and non-cardiac)
Time frame: 4 years
All deaths
All deaths (cardiac and non-cardiac)
Time frame: 5 years
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Time frame: 6 month
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Time frame: 9 month
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Time frame: 1 year
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Time frame: 2 years
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Time frame: 3 years
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Time frame: 4 years
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Time frame: 5 years
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Time frame: 6 month
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Time frame: 9 month
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Time frame: 1 year
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Time frame: 2 years
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Time frame: 3 years
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Time frame: 4 years
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Time frame: 5 years