Limus Eluted From A Durable Versus ERodable Stent Coating

Coronary Disease Clinical Trial

— LEADERS  

Official title:

A Randomized Comparison of a Biolimus-Eluting Stent With a Sirolimus-Eluting Stent for Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389220
• Other study ID #: 05EU01
• Status: Completed
• Phase: N/A
• Start date: November 2006
• Est. completion date: June 2012

Study information

• Verified date: May 2019
• Source: Biosensors Europe SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1707
• Est. completion date: June 2012
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis

Intervention

Device:
• Coronary stent placement
Coronary stent placement

Locations

Country	Name	City	State
Belgium	Onze Lieve Vrouw Ziekenhuis, Cardiologisch Centrum, Moorselbaan 164	Aalst
France	L'Institut Cardiovasculaire Paris Sud, Institut Hospitalier Jacques Cartier, Service de Coronarographie, 6, Avenue du Noyer Lambert	Massy
Germany	Herzzentrum Leipzig, Innere Medizin/Kardiologie, Struimpellstrasse 39	Leipzig
Germany	Klinikum Bogenhausen der Stad München, Abteilung für Kardiologie und Pnemlogie, Englschalkstrasse 77	Munich
Germany	Universitatsklinikum Munchen, Medizinische Klinik Kardiologie, Ziemssenstrasse 1	Munich
Netherlands	University Medical Center Rotterdam Erasmus, Thoraxcentrum	Rotterdam
Poland	American Heart of Poland Sp. z o.o.	Dabrowa Górnicza
Switzerland	Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern, Inselspital	Bern
Switzerland	University Hospital Zürich, Director of Invasive Cardiology, Rämistrasse 100	Zurich
United Kingdom	Royal Brompton Hospital, Sydney Street	London

Sponsors (1)

Lead Sponsor	Collaborator
Biosensors Europe SA

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Netherlands,  Poland,  Switzerland,  United Kingdom, 

References & Publications (5)

Garg S, Sarno G, Serruys PW, de Vries T, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, Di Mario C, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P, Windecker S. The twelve-month outcomes of a biolimus eluting stent — View Citation

Sarno G, Garg S, Onuma Y, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, van Geuns RJ, Eerdmans P, Garcia-Garcia HM, van Es GA, Goedhart D, de Vries T, Jüni P, Meier B, Windecker S, Serruys P. The impact of b — View Citation

Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P. Biolimus-eluting stent with biodegradable — View Citation

Wykrzykowska JJ, Räber L, de Vries T, Bressers M, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Regar E, Jüni P, Windecker S, Serruys PW. Biolimus-eluting biodegradable polymer versus sirolimus-eluting perma — View Citation

Wykrzykowska JJ, Serruys PW, Onuma Y, de Vries T, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S. Impact of vessel size on angiographic and clinical outcomes of re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	9 month
Secondary	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)	30 days
Secondary	Cardiac death	Cardiac death	30 days
Secondary	All deaths	All deaths (cardiac and non-cardiac)	30 days
Secondary	Myocardial infarction	Myocardial infarction (Q-wave and NQWMI)	30 days
Secondary	Angiographic and clinical stent thrombosis.	Angiographic and clinical stent thrombosis	30 days
Secondary	In-stent and in-segment binary restenosis rate as assessed by QCA.	In-stent and in-segment binary restenosis rate as assessed by QCA.	9 month
Secondary	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	9 month
Secondary	In-segment percent diameter stenosis (%DS).	In-segment percent diameter stenosis (%DS) as assessed by QCA	9 month
Secondary	In-stent and in-segment late luminal loss	In-stent and in-segment late luminal loss as assessed by QCA	9 month
Secondary	Device success, lesion success and procedural success.		at implant
Secondary	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)	6 month
Secondary	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)	1 year
Secondary	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)	2 years
Secondary	Cardiac death	Cardiac death	6 month
Secondary	Cardiac death	Cardiac death	9 month
Secondary	Cardiac death	Cardiac death	1 year
Secondary	Cardiac death	Cardiac death	2 year
Secondary	Cardiac death	Cardiac death	3 year
Secondary	Cardiac death	Cardiac death	4 year
Secondary	Cardiac death	Cardiac death	5 year
Secondary	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)	3 year
Secondary	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)	4 year
Secondary	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)	5 year
Secondary	All deaths	All deaths (cardiac and non-cardiac)	6 month
Secondary	All deaths	All deaths (cardiac and non-cardiac)	9 month
Secondary	All deaths	All deaths (cardiac and non-cardiac)	1 year
Secondary	All deaths	All deaths (cardiac and non-cardiac)	2 years
Secondary	All deaths	All deaths (cardiac and non-cardiac)	3 years
Secondary	All deaths	All deaths (cardiac and non-cardiac)	4 years
Secondary	All deaths	All deaths (cardiac and non-cardiac)	5 years
Secondary	Myocardial infarction	Myocardial infarction (Q-wave and NQWMI)	6 month
Secondary	Myocardial infarction	Myocardial infarction (Q-wave and NQWMI)	9 month
Secondary	Myocardial infarction	Myocardial infarction (Q-wave and NQWMI)	1 year
Secondary	Myocardial infarction	Myocardial infarction (Q-wave and NQWMI)	2 years
Secondary	Myocardial infarction	Myocardial infarction (Q-wave and NQWMI)	3 years
Secondary	Myocardial infarction	Myocardial infarction (Q-wave and NQWMI)	4 years
Secondary	Myocardial infarction	Myocardial infarction (Q-wave and NQWMI)	5 years
Secondary	Angiographic and clinical stent thrombosis.	Angiographic and clinical stent thrombosis	6 month
Secondary	Angiographic and clinical stent thrombosis.	Angiographic and clinical stent thrombosis	9 month
Secondary	Angiographic and clinical stent thrombosis.	Angiographic and clinical stent thrombosis	1 year
Secondary	Angiographic and clinical stent thrombosis.	Angiographic and clinical stent thrombosis	2 years
Secondary	Angiographic and clinical stent thrombosis.	Angiographic and clinical stent thrombosis	3 years
Secondary	Angiographic and clinical stent thrombosis.	Angiographic and clinical stent thrombosis	4 years
Secondary	Angiographic and clinical stent thrombosis.	Angiographic and clinical stent thrombosis	5 years