LEADERS: Limus Eluted From A Durable Versus ERodable Stent Coating

• Sponsor: Biosensors Europe SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00389220
• Collaborator: (none)
• Enrollment: 1,707
• Locations: 10
• Arms: 2
• Duration (Months): 67
• Patients Per Site: 170.7
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease; Coronary Stenosis	Device: Coronary stent placement	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1707 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized Comparison of a Biolimus-Eluting Stent With a Sirolimus-Eluting Stent for Percutaneous Coronary Intervention
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

1. Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [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 [30 days]

   Cardiac death

3. All deaths [30 days]

   All deaths (cardiac and non-cardiac)

4. Myocardial infarction [30 days]

   Myocardial infarction (Q-wave and NQWMI)

5. Angiographic and clinical stent thrombosis. [30 days]

   Angiographic and clinical stent thrombosis

6. In-stent and in-segment binary restenosis rate as assessed by QCA. [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. [9 month]

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

8. In-segment percent diameter stenosis (%DS). [9 month]

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

9. In-stent and in-segment late luminal loss [9 month]

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

10. Device success, lesion success and procedural success. [at implant]

11. Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [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. [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. [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 [6 month]

    Cardiac death

15. Cardiac death [9 month]

    Cardiac death

16. Cardiac death [1 year]

    Cardiac death

17. Cardiac death [2 year]

    Cardiac death

18. Cardiac death [3 year]

    Cardiac death

19. Cardiac death [4 year]

    Cardiac death

20. Cardiac death [5 year]

    Cardiac death

21. Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [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. [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. [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 [6 month]

    All deaths (cardiac and non-cardiac)

25. All deaths [9 month]

    All deaths (cardiac and non-cardiac)

26. All deaths [1 year]

    All deaths (cardiac and non-cardiac)

27. All deaths [2 years]

    All deaths (cardiac and non-cardiac)

28. All deaths [3 years]

    All deaths (cardiac and non-cardiac)

29. All deaths [4 years]

    All deaths (cardiac and non-cardiac)

30. All deaths [5 years]

    All deaths (cardiac and non-cardiac)

31. Myocardial infarction [6 month]

    Myocardial infarction (Q-wave and NQWMI)

32. Myocardial infarction [9 month]

    Myocardial infarction (Q-wave and NQWMI)

33. Myocardial infarction [1 year]

    Myocardial infarction (Q-wave and NQWMI)

34. Myocardial infarction [2 years]

    Myocardial infarction (Q-wave and NQWMI)

35. Myocardial infarction [3 years]

    Myocardial infarction (Q-wave and NQWMI)

36. Myocardial infarction [4 years]

    Myocardial infarction (Q-wave and NQWMI)

37. Myocardial infarction [5 years]

    Myocardial infarction (Q-wave and NQWMI)

38. Angiographic and clinical stent thrombosis. [6 month]

    Angiographic and clinical stent thrombosis

39. Angiographic and clinical stent thrombosis. [9 month]

    Angiographic and clinical stent thrombosis

40. Angiographic and clinical stent thrombosis. [1 year]

    Angiographic and clinical stent thrombosis

41. Angiographic and clinical stent thrombosis. [2 years]

    Angiographic and clinical stent thrombosis

42. Angiographic and clinical stent thrombosis. [3 years]

    Angiographic and clinical stent thrombosis

43. Angiographic and clinical stent thrombosis. [4 years]

    Angiographic and clinical stent thrombosis

44. Angiographic and clinical stent thrombosis. [5 years]

    Angiographic and clinical stent thrombosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Onze Lieve Vrouw Ziekenhuis, Cardiologisch Centrum, Moorselbaan 164	Aalst		Belgium	B-9300
2	L'Institut Cardiovasculaire Paris Sud, Institut Hospitalier Jacques Cartier, Service de Coronarographie, 6, Avenue du Noyer Lambert	Massy		France	91300
3	Herzzentrum Leipzig, Innere Medizin/Kardiologie, Struimpellstrasse 39	Leipzig		Germany	D-04289
4	Universitatsklinikum Munchen, Medizinische Klinik Kardiologie, Ziemssenstrasse 1	Munich		Germany	80336
5	Klinikum Bogenhausen der Stad München, Abteilung für Kardiologie und Pnemlogie, Englschalkstrasse 77	Munich		Germany	D-8000
6	University Medical Center Rotterdam Erasmus, Thoraxcentrum	Rotterdam		Netherlands	3015 GD
7	American Heart of Poland Sp. z o.o.	Dąbrowa Górnicza		Poland	43100
8	Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern, Inselspital	Bern		Switzerland	CH-3010
9	University Hospital Zürich, Director of Invasive Cardiology, Rämistrasse 100	Zurich		Switzerland	8091
10	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biosensors Europe SA
• ClinicalTrials.gov Identifier: NCT00389220
• Other Study ID Numbers: 05EU01
• First Posted: Oct 18, 2006
• Last Update Posted: May 7, 2019
• Last Verified: May 1, 2019

• Keywords provided by Biosensors Europe SA: Coronary Disease; Coronary Stenosis; Angioplasty; Coronary Restenosis; Drug Eluting Stent
• Additional relevant MeSH terms: Coronary Disease; Coronary Artery Disease; Coronary Stenosis

Study Results

No Results Posted as of May 7, 2019