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: September 23, 2013
Last verified: September 2013
  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:


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
Coronary stent placement with Biolimus A9 coated stent with biodegradable polymer
Device: Coronary stent placement
Coronary stent placement
Active Comparator: Cypher Select stent
Coronary stent placement with 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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

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: September 23, 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 July 20, 2014