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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

October 13, 2006
September 23, 2013
November 2006
May 2008   (final data collection date for primary outcome measure)
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)
  • Major adverse cardiac events (MACE) within 9 months in the overall population defined as
  • composite of cardiac death,
  • myocardial infarction (Q-wave and Non-Q wave)
  • justified target vessel revascularization
Complete list of historical versions of study NCT00389220 on ClinicalTrials.gov Archive Site
  • 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
  • Justified and non-justified target lesion revascularization (TLR)at 30 days, 6 months, 9 months, 1, 2, 3, 4 and 5 years.
  • Justified and non-justified target vessel revascularization (TVR)at 30 days, 6 months, 9 months, 1, 2, 3, 4 and 5 years.
  • Composite of cardiac death, myocardial infarction (Q wave and Non-Q wave), or justified target vessel revascularization at 30 days, 6 months, 1, 2, 3, 4 and 5 years.
  • Target Vessel Failure (TVF) at 30 days, 6 months, 9 months, 1, 2, 3, 4 and 5 years.
  • Cardiac death at 30 days, 6 months, 9 months, 1, 2, 3, 4 and 5 years.
  • All deaths (cardiac and non-cardiac) at 30 days, 6 months, 9 months, 1, 2, 3, 4 and 5 years.
  • Myocardial infarction (Q-wave and NQWMI) at 30 days, 6 months, 9 months, 1, 2, 3, 4 and 5 years.
  • Angiographic and clinical stent thrombosis at 30 days, 6 months, 9 months, 1, 2, 3, 4 and 5 years.
  • In-stent and in-segment binary restenosis rate as assessed by QCA at 9 months after stent implantation.
  • In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA at 9 months after stent implantation.
  • In-segment percent diameter stenosis (%DS) as assessed by QCA at 9 months after stent implantation.
  • In-stent and in-segment late luminal loss as assessed by QCA at 9 months.
  • Device success, lesion success and procedural success.
Not Provided
Not Provided
 
Limus Eluted From A Durable Versus ERodable Stent Coating
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Coronary Disease
  • Coronary Stenosis
Device: Coronary stent placement
Coronary stent placement
  • Active Comparator: BioMatrix Flex stent
    Coronary stent placement with Biolimus A9 coated stent with biodegradable polymer
    Intervention: Device: Coronary stent placement
  • Active Comparator: Cypher Select stent
    Coronary stent placement with Sirolimus coated stent with durable polymer
    Intervention: Device: Coronary stent placement

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1707
June 2012
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Netherlands,   Poland,   Switzerland,   United Kingdom
 
NCT00389220
05EU01
Yes
Biosensors Europe SA
Biosensors Europe SA
Not Provided
Principal Investigator: Stephan Windecker, Prof. Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern
Biosensors Europe SA
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP