Skip to main content
OpenTrials
Completed

NCT Number: NCT00389220

Limus Eluted From A Durable Versus ERodable Stent Coating

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Disease Cardiovascular Diseases Coronary Restenosis Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Onze Lieve Vrouw Ziekenhuis, Cardiologisch Centrum, Moorselbaan 164, Aalst, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary stent placement

Device

Coronary stent placement

Primary outcomes

  1. 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)

Secondary outcomes

  1. Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.

    Time frame: 30 days

    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. Cardiac death

    Time frame: 30 days

    Cardiac death

  3. All deaths

    Time frame: 30 days

    All deaths (cardiac and non-cardiac)

  4. Myocardial infarction

    Time frame: 30 days

    Myocardial infarction (Q-wave and NQWMI)

  5. Angiographic and clinical stent thrombosis.

    Time frame: 30 days

    Angiographic and clinical stent thrombosis

  6. In-stent and in-segment binary restenosis rate as assessed by QCA.

    Time frame: 9 month

    In-stent and in-segment binary restenosis rate as assessed by QCA.

  7. In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA.

    Time frame: 9 month

    In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA

  8. In-segment percent diameter stenosis (%DS).

    Time frame: 9 month

    In-segment percent diameter stenosis (%DS) as assessed by QCA

  9. In-stent and in-segment late luminal loss

    Time frame: 9 month

    In-stent and in-segment late luminal loss as assessed by QCA

  10. Device success, lesion success and procedural success.

    Time frame: at implant

  11. 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 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)

  12. 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 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)

  13. Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.

    Time frame: 2 years

    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)

  14. Cardiac death

    Time frame: 6 month

    Cardiac death

  15. Cardiac death

    Time frame: 9 month

    Cardiac death

  16. Cardiac death

    Time frame: 1 year

    Cardiac death

  17. Cardiac death

    Time frame: 2 year

    Cardiac death

  18. Cardiac death

    Time frame: 3 year

    Cardiac death

  19. Cardiac death

    Time frame: 4 year

    Cardiac death

  20. Cardiac death

    Time frame: 5 year

    Cardiac death

  21. 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 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)

  22. 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 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)

  23. Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.

    Time frame: 5 year

    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)

  24. All deaths

    Time frame: 6 month

    All deaths (cardiac and non-cardiac)

  25. All deaths

    Time frame: 9 month

    All deaths (cardiac and non-cardiac)

  26. All deaths

    Time frame: 1 year

    All deaths (cardiac and non-cardiac)

  27. All deaths

    Time frame: 2 years

    All deaths (cardiac and non-cardiac)

  28. All deaths

    Time frame: 3 years

    All deaths (cardiac and non-cardiac)

  29. All deaths

    Time frame: 4 years

    All deaths (cardiac and non-cardiac)

  30. All deaths

    Time frame: 5 years

    All deaths (cardiac and non-cardiac)

  31. Myocardial infarction

    Time frame: 6 month

    Myocardial infarction (Q-wave and NQWMI)

  32. Myocardial infarction

    Time frame: 9 month

    Myocardial infarction (Q-wave and NQWMI)

  33. Myocardial infarction

    Time frame: 1 year

    Myocardial infarction (Q-wave and NQWMI)

  34. Myocardial infarction

    Time frame: 2 years

    Myocardial infarction (Q-wave and NQWMI)

  35. Myocardial infarction

    Time frame: 3 years

    Myocardial infarction (Q-wave and NQWMI)

  36. Myocardial infarction

    Time frame: 4 years

    Myocardial infarction (Q-wave and NQWMI)

  37. Myocardial infarction

    Time frame: 5 years

    Myocardial infarction (Q-wave and NQWMI)

  38. Angiographic and clinical stent thrombosis.

    Time frame: 6 month

    Angiographic and clinical stent thrombosis

  39. Angiographic and clinical stent thrombosis.

    Time frame: 9 month

    Angiographic and clinical stent thrombosis

  40. Angiographic and clinical stent thrombosis.

    Time frame: 1 year

    Angiographic and clinical stent thrombosis

  41. Angiographic and clinical stent thrombosis.

    Time frame: 2 years

    Angiographic and clinical stent thrombosis

  42. Angiographic and clinical stent thrombosis.

    Time frame: 3 years

    Angiographic and clinical stent thrombosis

  43. Angiographic and clinical stent thrombosis.

    Time frame: 4 years

    Angiographic and clinical stent thrombosis

  44. Angiographic and clinical stent thrombosis.

    Time frame: 5 years

    Angiographic and clinical stent thrombosis

Sponsors and collaborators

Lead sponsor

Biosensors Europe SA

Industry

Registry information

Official study title

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

Acronym: LEADERS

Important dates

Study start
2006
Primary completion
2008
Study completion
2012
First posted
Oct 18, 2006
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.