Coronary DiseaseLEADERSNCT00389220

Limus Eluted From A Durable Versus ERodable Stent Coating

A study testing Coronary stent placement in people with Coronary Disease and Coronary Stenosis, run by Biosensors Europe SA at 10 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Disease, Coronary Stenosis
What is being tested?: Coronary stent placement
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,707 participants
Where: 10 sitesin 7 countries
Study dates: Nov 2006to Jun 2012
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

10 sites in 7 countries.

Country

City, postcode or hospital

10 sites in 7 countries

Germany3 sites

Herzzentrum Leipzig, Innere Medizin/Kardiologie, Struimpellstrasse 39
Leipzig, D-04289
Universitatsklinikum Munchen, Medizinische Klinik Kardiologie, Ziemssenstrasse 1
Munich, 80336
Klinikum Bogenhausen der Stad München, Abteilung für Kardiologie und Pnemlogie, Englschalkstrasse 77
Munich, D-8000

Other trials in Germany

Switzerland2 sites

Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern, Inselspital
Bern, CH-3010
University Hospital Zürich, Director of Invasive Cardiology, Rämistrasse 100
Zurich, 8091

Other trials in Switzerland

Belgium1 site

Onze Lieve Vrouw Ziekenhuis, Cardiologisch Centrum, Moorselbaan 164
Aalst, B-9300

Other trials in Belgium

France1 site

L'Institut Cardiovasculaire Paris Sud, Institut Hospitalier Jacques Cartier, Service de Coronarographie, 6, Avenue du Noyer Lambert
Massy, 91300

Other trials in France

Netherlands1 site

University Medical Center Rotterdam Erasmus, Thoraxcentrum
Rotterdam, 3015 GD

Other trials in Netherlands

Poland1 site

American Heart of Poland Sp. z o.o.
Dąbrowa Górnicza, 43100

Other trials in Poland

United Kingdom1 site

Royal Brompton Hospital, Sydney Street
London, SW3 6NP

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Conditions: Coronary Disease, Coronary Stenosis
Being tested: Coronary stent placement
Keywords: Coronary Disease, Coronary Stenosis, Angioplasty, Coronary Restenosis, Drug Eluting Stent
Medical subject headings: Coronary Disease, Coronary Stenosis, Coronary Restenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Coronary stent placementDevice
Coronary stent placement

Study groups in NCT00389220
Study group	Role	What they receive
BioMatrix Flex stent	Active comparator	Coronary stent placement with Biolimus A9 coated stent with biodegradable polymer Receives: Device: Coronary stent placement
Cypher Select stent	Active comparator	Coronary stent placement with Sirolimus coated stent with durable polymer Receives: Device: Coronary stent placement

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 9 month

Secondary outcomes (44)

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)
Measured: 30 days
Cardiac death
Cardiac death
Measured: 30 days
All deaths
All deaths (cardiac and non-cardiac)
Measured: 30 days
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Measured: 30 days
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Measured: 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.
Measured: 9 month
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
Measured: 9 month
In-segment percent diameter stenosis (%DS).
In-segment percent diameter stenosis (%DS) as assessed by QCA
Measured: 9 month
In-stent and in-segment late luminal loss
In-stent and in-segment late luminal loss as assessed by QCA
Measured: 9 month
Device success, lesion success and procedural success.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 2 years
Cardiac death
Cardiac death
Measured: 6 month
Cardiac death
Cardiac death
Measured: 9 month
Cardiac death
Cardiac death
Measured: 1 year
Cardiac death
Cardiac death
Measured: 2 year
Cardiac death
Cardiac death
Measured: 3 year
Cardiac death
Cardiac death
Measured: 4 year
Cardiac death
Cardiac death
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 5 year
All deaths
All deaths (cardiac and non-cardiac)
Measured: 6 month
All deaths
All deaths (cardiac and non-cardiac)
Measured: 9 month
All deaths
All deaths (cardiac and non-cardiac)
Measured: 1 year
All deaths
All deaths (cardiac and non-cardiac)
Measured: 2 years
All deaths
All deaths (cardiac and non-cardiac)
Measured: 3 years
All deaths
All deaths (cardiac and non-cardiac)
Measured: 4 years
All deaths
All deaths (cardiac and non-cardiac)
Measured: 5 years
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Measured: 6 month
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Measured: 9 month
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Measured: 1 year
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Measured: 2 years
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Measured: 3 years
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Measured: 4 years
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Measured: 5 years
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Measured: 6 month
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Measured: 9 month
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Measured: 1 year
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Measured: 2 years
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Measured: 3 years
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Measured: 4 years
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Jun 2012

First posted18 Oct 2006 (estimated)
Study startNov 2006
Primary completionMay 2008
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Coronary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 1,707 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00389220
Sponsor's protocol ID: 05EU01
Acronym: LEADERS
Status last verified: May 2019
First submitted: 13 Oct 2006
Last updated: 7 May 2019
Results posted: No
Data monitoring committee: Yes

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, Juni 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. doi: 10.1016/S0140-6736(08)61244-1. Epub 2008 Aug 31.
PubMed 18765162
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, Juni 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.
PubMed 20562074
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, Juni 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. doi: 10.1016/j.amjcard.2009.09.055. Epub 2010 Jan 5.
PubMed 20152241
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. doi: 10.1016/j.jcin.2009.05.024.
PubMed 19778775
Wykrzykowska JJ, Raber 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, Juni 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. doi: 10.4244/v5i3a49.
PubMed 19736154
Yuan H, Wu Z, Lu T, Wei T, Zeng Y, Liu Y, Huang C. Comparison of biodegradable and durable polymer drug-eluting stents in acute coronary syndrome: a meta-analysis. BMJ Open. 2022 Jun 8;12(6):e058075. doi: 10.1136/bmjopen-2021-058075.
PubMed 35676012
Koskinas KC, Siontis GC, Piccolo R, Franzone A, Haynes A, Rat-Wirtzler J, Silber S, Serruys PW, Pilgrim T, Raber L, Heg D, Juni P, Windecker S. Impact of Diabetic Status on Outcomes After Revascularization With Drug-Eluting Stents in Relation to Coronary Artery Disease Complexity: Patient-Level Pooled Analysis of 6081 Patients. Circ Cardiovasc Interv. 2016 Feb;9(2):e003255. doi: 10.1161/CIRCINTERVENTIONS.115.003255.
PubMed 26823484
Grundeken MJ, Wykrzykowska JJ, Ishibashi Y, Garg S, de Vries T, Garcia-Garcia HM, Onuma Y, de Winter RJ, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Meier B, Juni P, Yazdani A, Copt S, Windecker S, Serruys PW. First generation versus second generation drug-eluting stents for the treatment of bifurcations: 5-year follow-up of the LEADERS all-comers randomized trial. Catheter Cardiovasc Interv. 2016 Jun;87(7):E248-60. doi: 10.1002/ccd.26344. Epub 2015 Dec 9.
PubMed 26649651
Zhang YJ, Iqbal J, Windecker S, Linke A, Antoni D, Sohn HY, Corti R, van Es GA, Copt S, Eerdmans P, Saitta R, Morice MC, Di Mario C, Juni P, Wijns W, Buszman P, Serruys PW. Biolimus-eluting stent with biodegradable polymer improves clinical outcomes in patients with acute myocardial infarction. Heart. 2015 Feb;101(4):271-8. doi: 10.1136/heartjnl-2014-306359. Epub 2014 Nov 25.
PubMed 25423953
Vranckx P, Kalesan B, Stefanini GG, Farooq V, Onuma Y, Silber S, de Vries T, Juni P, Serruys PW, Windecker S. Clinical outcome of patients with stable ischaemic heart disease as compared to those with acute coronary syndromes after percutaneous coronary intervention. EuroIntervention. 2015 Jun;11(2):171-9. doi: 10.4244/EIJV11I2A31.
PubMed 24531331
Serruys PW, Farooq V, Kalesan B, de Vries T, 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, Rademaker-Havinga T, van Es GA, Meier B, Juni P, Windecker S. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. JACC Cardiovasc Interv. 2013 Aug;6(8):777-89. doi: 10.1016/j.jcin.2013.04.011.
PubMed 23968698
Gutierrez-Chico JL, Raber L, Regar E, Okamura T, di Mario C, van Es GA, Windecker S, Serruys PW. Tissue coverage and neointimal hyperplasia in overlap versus nonoverlap segments of drug-eluting stents 9 to 13 months after implantation: in vivo assessment with optical coherence tomography. Am Heart J. 2013 Jul;166(1):83-94. doi: 10.1016/j.ahj.2013.04.001. Epub 2013 May 3.
PubMed 23816026
Stefanini GG, Kalesan B, Pilgrim T, Raber L, Onuma Y, Silber S, Serruys PW, Meier B, Juni 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. doi: 10.1016/j.jcin.2011.11.011.
PubMed 22440496
Gutierrez-Chico JL, Juni P, Garcia-Garcia HM, Regar E, Nuesch 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. doi: 10.1016/j.ahj.2011.09.005. Epub 2011 Oct 7.
PubMed 22093210
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, Juni 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. doi: 10.1016/S0140-6736(11)61672-3. Epub 2011 Nov 8.
PubMed 22075451

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Comparison of a Biolimus-Eluting Stent With a Sirolimus-Eluting Stent for Percutaneous Coronary Intervention
ClinicalTrials.gov ID: NCT00389220
Acronym / sponsor ID: LEADERS / 05EU01
Conditions: Coronary Disease, Coronary Stenosis
Keywords: Coronary Disease, Coronary Stenosis, Angioplasty, Coronary Restenosis, Drug Eluting Stent
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,707 participants (actual)
Lead sponsor: Biosensors Europe SAIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: May 2008 (actual)
Study completion: Jun 2012 (actual)
First posted: 18 Oct 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
BioMatrix Flex stent	Active comparator	Device: Coronary stent placementCoronary stent placement with Biolimus A9 coated stent with biodegradable polymer
Cypher Select stent	Active comparator	Device: Coronary stent placementCoronary stent placement with Sirolimus coated stent with durable polymer

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Coronary stent placementCoronary stent placement	Device	BioMatrix Flex stent, Cypher Select stent

Primary outcome

Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Time frame: 9 month
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)

44 secondary outcomes

Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Time frame: 30 days
Cardiac death
Time frame: 30 days
All deaths
Time frame: 30 days
Myocardial infarction
Time frame: 30 days
Angiographic and clinical stent thrombosis.
Time frame: 30 days
In-stent and in-segment binary restenosis rate as assessed by QCA.
Time frame: 9 month
In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA.
Time frame: 9 month
In-segment percent diameter stenosis (%DS).
Time frame: 9 month
In-stent and in-segment late luminal loss
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.
Time frame: 6 month
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Time frame: 1 year
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Time frame: 2 years
Cardiac death
Time frame: 6 month
Cardiac death
Time frame: 9 month
Cardiac death
Time frame: 1 year
Cardiac death
Time frame: 2 year
Cardiac death
Time frame: 3 year
Cardiac death
Time frame: 4 year
Cardiac death
Time frame: 5 year
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Time frame: 3 year
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Time frame: 4 year
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Time frame: 5 year
All deaths
Time frame: 6 month
All deaths
Time frame: 9 month
All deaths
Time frame: 1 year
All deaths
Time frame: 2 years
All deaths
Time frame: 3 years
All deaths
Time frame: 4 years
All deaths
Time frame: 5 years
Myocardial infarction
Time frame: 6 month
Myocardial infarction
Time frame: 9 month
Myocardial infarction
Time frame: 1 year
Myocardial infarction
Time frame: 2 years
Myocardial infarction
Time frame: 3 years
Myocardial infarction
Time frame: 4 years
Myocardial infarction
Time frame: 5 years
Angiographic and clinical stent thrombosis.
Time frame: 6 month
Angiographic and clinical stent thrombosis.
Time frame: 9 month
Angiographic and clinical stent thrombosis.
Time frame: 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
Results publication: PubMed 18765162Windecker 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, Juni 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. doi: 10.1016/S0140-6736(08)61244-1. Epub 2008 Aug 31.
Results publication: PubMed 20562074Garg 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, Juni 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.
Results publication: PubMed 20152241Sarno 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, Juni 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. doi: 10.1016/j.amjcard.2009.09.055. Epub 2010 Jan 5.
Results publication: PubMed 19778775Wykrzykowska 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. doi: 10.1016/j.jcin.2009.05.024.
Results publication: PubMed 19736154Wykrzykowska JJ, Raber 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, Juni 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. doi: 10.4244/v5i3a49.
Derived from this study: PubMed 35676012Yuan H, Wu Z, Lu T, Wei T, Zeng Y, Liu Y, Huang C. Comparison of biodegradable and durable polymer drug-eluting stents in acute coronary syndrome: a meta-analysis. BMJ Open. 2022 Jun 8;12(6):e058075. doi: 10.1136/bmjopen-2021-058075.
Derived from this study: PubMed 26823484Koskinas KC, Siontis GC, Piccolo R, Franzone A, Haynes A, Rat-Wirtzler J, Silber S, Serruys PW, Pilgrim T, Raber L, Heg D, Juni P, Windecker S. Impact of Diabetic Status on Outcomes After Revascularization With Drug-Eluting Stents in Relation to Coronary Artery Disease Complexity: Patient-Level Pooled Analysis of 6081 Patients. Circ Cardiovasc Interv. 2016 Feb;9(2):e003255. doi: 10.1161/CIRCINTERVENTIONS.115.003255.
Derived from this study: PubMed 26649651Grundeken MJ, Wykrzykowska JJ, Ishibashi Y, Garg S, de Vries T, Garcia-Garcia HM, Onuma Y, de Winter RJ, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Meier B, Juni P, Yazdani A, Copt S, Windecker S, Serruys PW. First generation versus second generation drug-eluting stents for the treatment of bifurcations: 5-year follow-up of the LEADERS all-comers randomized trial. Catheter Cardiovasc Interv. 2016 Jun;87(7):E248-60. doi: 10.1002/ccd.26344. Epub 2015 Dec 9.
Derived from this study: PubMed 25423953Zhang YJ, Iqbal J, Windecker S, Linke A, Antoni D, Sohn HY, Corti R, van Es GA, Copt S, Eerdmans P, Saitta R, Morice MC, Di Mario C, Juni P, Wijns W, Buszman P, Serruys PW. Biolimus-eluting stent with biodegradable polymer improves clinical outcomes in patients with acute myocardial infarction. Heart. 2015 Feb;101(4):271-8. doi: 10.1136/heartjnl-2014-306359. Epub 2014 Nov 25.
Derived from this study: PubMed 24531331Vranckx P, Kalesan B, Stefanini GG, Farooq V, Onuma Y, Silber S, de Vries T, Juni P, Serruys PW, Windecker S. Clinical outcome of patients with stable ischaemic heart disease as compared to those with acute coronary syndromes after percutaneous coronary intervention. EuroIntervention. 2015 Jun;11(2):171-9. doi: 10.4244/EIJV11I2A31.
Derived from this study: PubMed 23968698Serruys PW, Farooq V, Kalesan B, de Vries T, 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, Rademaker-Havinga T, van Es GA, Meier B, Juni P, Windecker S. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. JACC Cardiovasc Interv. 2013 Aug;6(8):777-89. doi: 10.1016/j.jcin.2013.04.011.
Derived from this study: PubMed 23816026Gutierrez-Chico JL, Raber L, Regar E, Okamura T, di Mario C, van Es GA, Windecker S, Serruys PW. Tissue coverage and neointimal hyperplasia in overlap versus nonoverlap segments of drug-eluting stents 9 to 13 months after implantation: in vivo assessment with optical coherence tomography. Am Heart J. 2013 Jul;166(1):83-94. doi: 10.1016/j.ahj.2013.04.001. Epub 2013 May 3.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephan Windecker, Prof. principal investigator

Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern

10 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Coronary stent placement in people with Coronary Disease and Coronary Stenosis, run by Biosensors Europe SA at 10 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany, Switzerland, Belgium, France, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. (time frame: 9 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00389220, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.