Limus Eluted From A Durable Versus ERodable Stent Coating (LEADERS)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Biosensors Europe SA

ClinicalTrials.gov Identifier:

NCT00389220

First received: October 13, 2006

Last updated: June 13, 2013

Last verified: June 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Coronary Disease Coronary Stenosis	Device: Coronary stent placement	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Randomized Comparison of a Biolimus-Eluting Stent With a Sirolimus-Eluting Stent for Percutaneous Coronary Intervention

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Attack

U.S. FDA Resources

Further study details as provided by Biosensors Europe SA:

Primary Outcome Measures:

Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 9 month ] [ Designated as safety issue: No ]
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)

Secondary Outcome Measures:

Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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)
Cardiac death [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Cardiac death
All deaths [ Time Frame: 30 days ] [ Designated as safety issue: No ]
All deaths (cardiac and non-cardiac)
Myocardial infarction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Myocardial infarction (Q-wave and NQWMI)
Angiographic and clinical stent thrombosis. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Angiographic and clinical stent thrombosis
In-stent and in-segment binary restenosis rate as assessed by QCA. [ Time Frame: 9 month ] [ Designated as safety issue: No ]
In-stent and in-segment binary restenosis rate as assessed by QCA.
In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA. [ Time Frame: 9 month ] [ Designated as safety issue: No ]
In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA
In-segment percent diameter stenosis (%DS). [ Time Frame: 9 month ] [ Designated as safety issue: No ]
In-segment percent diameter stenosis (%DS) as assessed by QCA
In-stent and in-segment late luminal loss [ Time Frame: 9 month ] [ Designated as safety issue: No ]
In-stent and in-segment late luminal loss as assessed by QCA
Device success, lesion success and procedural success. [ Time Frame: at implant ] [ Designated as safety issue: No ]
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
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)
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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)
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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)
Cardiac death [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Cardiac death
Cardiac death [ Time Frame: 9 month ] [ Designated as safety issue: No ]
Cardiac death
Cardiac death [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Cardiac death
Cardiac death [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Cardiac death
Cardiac death [ Time Frame: 3 year ] [ Designated as safety issue: No ]
Cardiac death
Cardiac death [ Time Frame: 4 year ] [ Designated as safety issue: No ]
Cardiac death
Cardiac death [ Time Frame: 5 year ] [ Designated as safety issue: No ]
Cardiac death
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 3 year ] [ Designated as safety issue: No ]
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)
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 4 year ] [ Designated as safety issue: No ]
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)
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 5 year ] [ Designated as safety issue: No ]
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)
All deaths [ Time Frame: 6 month ] [ Designated as safety issue: No ]
All deaths (cardiac and non-cardiac)
All deaths [ Time Frame: 9 month ] [ Designated as safety issue: No ]
All deaths (cardiac and non-cardiac)
All deaths [ Time Frame: 1 year ] [ Designated as safety issue: No ]
All deaths (cardiac and non-cardiac)
All deaths [ Time Frame: 2 years ] [ Designated as safety issue: No ]
All deaths (cardiac and non-cardiac)
All deaths [ Time Frame: 3 years ] [ Designated as safety issue: No ]
All deaths (cardiac and non-cardiac)
All deaths [ Time Frame: 4 years ] [ Designated as safety issue: No ]
All deaths (cardiac and non-cardiac)
All deaths [ Time Frame: 5 years ] [ Designated as safety issue: No ]
All deaths (cardiac and non-cardiac)
Myocardial infarction [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Myocardial infarction (Q-wave and NQWMI)
Myocardial infarction [ Time Frame: 9 month ] [ Designated as safety issue: No ]
Myocardial infarction (Q-wave and NQWMI)
Myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Myocardial infarction (Q-wave and NQWMI)
Myocardial infarction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Myocardial infarction (Q-wave and NQWMI)
Myocardial infarction [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Myocardial infarction (Q-wave and NQWMI)
Myocardial infarction [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Myocardial infarction (Q-wave and NQWMI)
Myocardial infarction [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Myocardial infarction (Q-wave and NQWMI)
Angiographic and clinical stent thrombosis. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis. [ Time Frame: 9 month ] [ Designated as safety issue: No ]
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Angiographic and clinical stent thrombosis

Enrollment:	1707
Study Start Date:	November 2006
Study Completion Date:	June 2012
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: BioMatrix Flex stent Biolimus A9 coated stent with biodegradable polymer	Device: Coronary stent placement Coronary stent placement
Active Comparator: Cypher Select stent Sirolimus coated stent with durable polymer	Device: Coronary stent placement Coronary stent placement

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389220

Locations

Belgium
Onze Lieve Vrouw Ziekenhuis, Cardiologisch Centrum, Moorselbaan 164
Aalst, Belgium, B-9300
France
L'Institut Cardiovasculaire Paris Sud, Institut Hospitalier Jacques Cartier, Service de Coronarographie, 6, Avenue du Noyer Lambert
Massy, France, 91300
Germany
Herzzentrum Leipzig, Innere Medizin/Kardiologie, Struimpellstrasse 39
Leipzig, Germany, D-04289
Klinikum Bogenhausen der Stad München, Abteilung für Kardiologie und Pnemlogie, Englschalkstrasse 77
Munich, Germany, D-8000
Universitatsklinikum Munchen, Medizinische Klinik Kardiologie, Ziemssenstrasse 1
Munich, Germany, 80336
Netherlands
University Medical Center Rotterdam Erasmus, Thoraxcentrum
Rotterdam, Netherlands, 3015 GD
Poland
American Heart of Poland Sp. z o.o.
Dąbrowa Górnicza, Poland, 43100
Switzerland
Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern, Inselspital
Bern, Switzerland, CH-3010
University Hospital Zürich, Director of Invasive Cardiology, Rämistrasse 100
Zurich, Switzerland, 8091
United Kingdom
Royal Brompton Hospital, Sydney Street
London, United Kingdom, SW3 6NP

Sponsors and Collaborators

Biosensors Europe SA

Investigators

Principal Investigator:

Stephan Windecker, Prof.

Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern

More Information

Publications:

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 polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008 Sep 27;372(9644):1163-73. Epub 2008 Aug 31.

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 with a biodegradable polymer compared with a sirolimus eluting stent with a durable polymer. EuroIntervention. 2010 Jun;6(2):233-9.

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 body mass index on the one year outcomes of patients treated by percutaneous coronary intervention with Biolimus- and Sirolimus-eluting stents (from the LEADERS Trial). Am J Cardiol. 2010 Feb 15;105(4):475-9. Epub 2010 Jan 5.

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 revascularization with biolimus-eluting stent with biodegradable polymer and sirolimus-eluting stent with durable polymer the LEADERS trial substudy. JACC Cardiovasc Interv. 2009 Sep;2(9):861-70.

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 permanent polymer stent performance in long lesions: results from the LEADERS multicentre trial substudy. EuroIntervention. 2009 Aug;5(3):310-7.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stefanini GG, Kalesan B, Pilgrim T, Räber L, Onuma Y, Silber S, Serruys PW, Meier B, Jüni P, Windecker S. Impact of sex on clinical and angiographic outcomes among patients undergoing revascularization with drug-eluting stents. JACC Cardiovasc Interv. 2012 Mar;5(3):301-10.

Gutiérrez-Chico JL, Jüni P, García-García HM, Regar E, Nüesch E, Borgia F, van der Giessen WJ, Davies S, van Geuns RJ, Secco GG, Meis S, Windecker S, Serruys PW, di Mario C. Long-term tissue coverage of a biodegradable polylactide polymer-coated biolimus-eluting stent: comparative sequential assessment with optical coherence tomography until complete resorption of the polymer. Am Heart J. 2011 Nov;162(5):922-31. Epub 2011 Oct 7.

Stefanini GG, Kalesan B, Serruys PW, Heg D, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, van Es GA, Meier B, Windecker S, Jüni P. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial. Lancet. 2011 Dec 3;378(9807):1940-8. Epub 2011 Nov 8.

Klauss V, Serruys PW, Pilgrim T, Buszman P, Linke A, Ischinger T, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, van Geuns RJ, van Es GA, Kalesan B, Wenaweser P, Jüni P, Windecker S. 2-year clinical follow-up from the randomized comparison of biolimus-eluting stents with biodegradable polymer and sirolimus-eluting stents with durable polymer in routine clinical practice. JACC Cardiovasc Interv. 2011 Aug;4(8):887-95.

Gutiérrez-Chico JL, Regar E, Nüesch E, Okamura T, Wykrzykowska J, di Mario C, Windecker S, van Es GA, Gobbens P, Jüni P, Serruys PW. Delayed coverage in malapposed and side-branch struts with respect to well-apposed struts in drug-eluting stents: in vivo assessment with optical coherence tomography. Circulation. 2011 Aug 2;124(5):612-23. Epub 2011 Jul 18.

Wykrzykowska JJ, Garg S, Onuma Y, de Vries T, Goedhart D, Morel MA, 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, Serruys PW. Value of age, creatinine, and ejection fraction (ACEF score) in assessing risk in patients undergoing percutaneous coronary interventions in the 'All-Comers' LEADERS trial. Circ Cardiovasc Interv. 2011 Feb 1;4(1):47-56. Epub 2011 Jan 4.

Wykrzykowska JJ, Garg S, Girasis C, de Vries T, Morel MA, 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, Serruys PW. Value of the SYNTAX score for risk assessment in the all-comers population of the randomized multicenter LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) trial. J Am Coll Cardiol. 2010 Jul 20;56(4):272-7.

Responsible Party:	Biosensors Europe SA
ClinicalTrials.gov Identifier:	NCT00389220 History of Changes
Other Study ID Numbers:	05EU01
Study First Received:	October 13, 2006
Last Updated:	June 13, 2013
Health Authority:	Germany: Ethics Commission

Keywords provided by Biosensors Europe SA:

Coronary Disease
Coronary Stenosis
Angioplasty
Coronary Restenosis
Drug Eluting Stent

Additional relevant MeSH terms:

Constriction, Pathologic
Coronary Disease
Coronary Artery Disease
Coronary Stenosis
Pathological Conditions, Anatomical
Myocardial Ischemia

Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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