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Limus Eluted From A Durable Versus ERodable Stent Coating (LEADERS)

Primary Purpose

Coronary Disease, Coronary Stenosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Coronary stent placement
Sponsored by
Biosensors Europe SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Coronary Disease, Coronary Stenosis, Angioplasty, Coronary Restenosis, Drug Eluting Stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Onze Lieve Vrouw Ziekenhuis, Cardiologisch Centrum, Moorselbaan 164
  • L'Institut Cardiovasculaire Paris Sud, Institut Hospitalier Jacques Cartier, Service de Coronarographie, 6, Avenue du Noyer Lambert
  • Herzzentrum Leipzig, Innere Medizin/Kardiologie, Struimpellstrasse 39
  • Universitatsklinikum Munchen, Medizinische Klinik Kardiologie, Ziemssenstrasse 1
  • Klinikum Bogenhausen der Stad München, Abteilung für Kardiologie und Pnemlogie, Englschalkstrasse 77
  • University Medical Center Rotterdam Erasmus, Thoraxcentrum
  • American Heart of Poland Sp. z o.o.
  • Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern, Inselspital
  • University Hospital Zürich, Director of Invasive Cardiology, Rämistrasse 100
  • Royal Brompton Hospital, Sydney Street

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

BioMatrix Flex stent

Cypher Select stent

Arm Description

Coronary stent placement with Biolimus A9 coated stent with biodegradable polymer

Coronary stent placement with Sirolimus coated stent with durable polymer

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Cardiac death
Cardiac death
All deaths
All deaths (cardiac and non-cardiac)
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
In-stent and in-segment binary restenosis rate as assessed by QCA.
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.
In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA
In-segment percent diameter stenosis (%DS).
In-segment percent diameter stenosis (%DS) as assessed by QCA
In-stent and in-segment late luminal loss
In-stent and in-segment late luminal loss as assessed by QCA
Device success, lesion success and procedural success.
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)
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)
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)
Cardiac death
Cardiac death
Cardiac death
Cardiac death
Cardiac death
Cardiac death
Cardiac death
Cardiac death
Cardiac death
Cardiac death
Cardiac death
Cardiac death
Cardiac death
Cardiac death
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)
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)
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)
All deaths
All deaths (cardiac and non-cardiac)
All deaths
All deaths (cardiac and non-cardiac)
All deaths
All deaths (cardiac and non-cardiac)
All deaths
All deaths (cardiac and non-cardiac)
All deaths
All deaths (cardiac and non-cardiac)
All deaths
All deaths (cardiac and non-cardiac)
All deaths
All deaths (cardiac and non-cardiac)
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Myocardial infarction
Myocardial infarction (Q-wave and NQWMI)
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis
Angiographic and clinical stent thrombosis.
Angiographic and clinical stent thrombosis

Full Information

First Posted
October 13, 2006
Last Updated
May 3, 2019
Sponsor
Biosensors Europe SA
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1. Study Identification

Unique Protocol Identification Number
NCT00389220
Brief Title
Limus Eluted From A Durable Versus ERodable Stent Coating
Acronym
LEADERS
Official Title
A Randomized Comparison of a Biolimus-Eluting Stent With a Sirolimus-Eluting Stent for Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosensors Europe SA

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Coronary Stenosis
Keywords
Coronary Disease, Coronary Stenosis, Angioplasty, Coronary Restenosis, Drug Eluting Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1707 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BioMatrix Flex stent
Arm Type
Active Comparator
Arm Description
Coronary stent placement with Biolimus A9 coated stent with biodegradable polymer
Arm Title
Cypher Select stent
Arm Type
Active Comparator
Arm Description
Coronary stent placement with Sirolimus coated stent with durable polymer
Intervention Type
Device
Intervention Name(s)
Coronary stent placement
Intervention Description
Coronary stent placement
Primary Outcome Measure Information:
Title
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Description
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)
Time Frame
9 month
Secondary Outcome Measure Information:
Title
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Description
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)
Time Frame
30 days
Title
Cardiac death
Description
Cardiac death
Time Frame
30 days
Title
All deaths
Description
All deaths (cardiac and non-cardiac)
Time Frame
30 days
Title
Myocardial infarction
Description
Myocardial infarction (Q-wave and NQWMI)
Time Frame
30 days
Title
Angiographic and clinical stent thrombosis.
Description
Angiographic and clinical stent thrombosis
Time Frame
30 days
Title
In-stent and in-segment binary restenosis rate as assessed by QCA.
Description
In-stent and in-segment binary restenosis rate as assessed by QCA.
Time Frame
9 month
Title
In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA.
Description
In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA
Time Frame
9 month
Title
In-segment percent diameter stenosis (%DS).
Description
In-segment percent diameter stenosis (%DS) as assessed by QCA
Time Frame
9 month
Title
In-stent and in-segment late luminal loss
Description
In-stent and in-segment late luminal loss as assessed by QCA
Time Frame
9 month
Title
Device success, lesion success and procedural success.
Time Frame
at implant
Title
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Description
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)
Time Frame
6 month
Title
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Description
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)
Time Frame
1 year
Title
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Description
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)
Time Frame
2 years
Title
Cardiac death
Description
Cardiac death
Time Frame
6 month
Title
Cardiac death
Description
Cardiac death
Time Frame
9 month
Title
Cardiac death
Description
Cardiac death
Time Frame
1 year
Title
Cardiac death
Description
Cardiac death
Time Frame
2 year
Title
Cardiac death
Description
Cardiac death
Time Frame
3 year
Title
Cardiac death
Description
Cardiac death
Time Frame
4 year
Title
Cardiac death
Description
Cardiac death
Time Frame
5 year
Title
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Description
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)
Time Frame
3 year
Title
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Description
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)
Time Frame
4 year
Title
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.
Description
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)
Time Frame
5 year
Title
All deaths
Description
All deaths (cardiac and non-cardiac)
Time Frame
6 month
Title
All deaths
Description
All deaths (cardiac and non-cardiac)
Time Frame
9 month
Title
All deaths
Description
All deaths (cardiac and non-cardiac)
Time Frame
1 year
Title
All deaths
Description
All deaths (cardiac and non-cardiac)
Time Frame
2 years
Title
All deaths
Description
All deaths (cardiac and non-cardiac)
Time Frame
3 years
Title
All deaths
Description
All deaths (cardiac and non-cardiac)
Time Frame
4 years
Title
All deaths
Description
All deaths (cardiac and non-cardiac)
Time Frame
5 years
Title
Myocardial infarction
Description
Myocardial infarction (Q-wave and NQWMI)
Time Frame
6 month
Title
Myocardial infarction
Description
Myocardial infarction (Q-wave and NQWMI)
Time Frame
9 month
Title
Myocardial infarction
Description
Myocardial infarction (Q-wave and NQWMI)
Time Frame
1 year
Title
Myocardial infarction
Description
Myocardial infarction (Q-wave and NQWMI)
Time Frame
2 years
Title
Myocardial infarction
Description
Myocardial infarction (Q-wave and NQWMI)
Time Frame
3 years
Title
Myocardial infarction
Description
Myocardial infarction (Q-wave and NQWMI)
Time Frame
4 years
Title
Myocardial infarction
Description
Myocardial infarction (Q-wave and NQWMI)
Time Frame
5 years
Title
Angiographic and clinical stent thrombosis.
Description
Angiographic and clinical stent thrombosis
Time Frame
6 month
Title
Angiographic and clinical stent thrombosis.
Description
Angiographic and clinical stent thrombosis
Time Frame
9 month
Title
Angiographic and clinical stent thrombosis.
Description
Angiographic and clinical stent thrombosis
Time Frame
1 year
Title
Angiographic and clinical stent thrombosis.
Description
Angiographic and clinical stent thrombosis
Time Frame
2 years
Title
Angiographic and clinical stent thrombosis.
Description
Angiographic and clinical stent thrombosis
Time Frame
3 years
Title
Angiographic and clinical stent thrombosis.
Description
Angiographic and clinical stent thrombosis
Time Frame
4 years
Title
Angiographic and clinical stent thrombosis.
Description
Angiographic and clinical stent thrombosis
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Windecker, Prof.
Organizational Affiliation
Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onze Lieve Vrouw Ziekenhuis, Cardiologisch Centrum, Moorselbaan 164
City
Aalst
ZIP/Postal Code
B-9300
Country
Belgium
Facility Name
L'Institut Cardiovasculaire Paris Sud, Institut Hospitalier Jacques Cartier, Service de Coronarographie, 6, Avenue du Noyer Lambert
City
Massy
ZIP/Postal Code
91300
Country
France
Facility Name
Herzzentrum Leipzig, Innere Medizin/Kardiologie, Struimpellstrasse 39
City
Leipzig
ZIP/Postal Code
D-04289
Country
Germany
Facility Name
Universitatsklinikum Munchen, Medizinische Klinik Kardiologie, Ziemssenstrasse 1
City
Munich
ZIP/Postal Code
80336
Country
Germany
Facility Name
Klinikum Bogenhausen der Stad München, Abteilung für Kardiologie und Pnemlogie, Englschalkstrasse 77
City
Munich
ZIP/Postal Code
D-8000
Country
Germany
Facility Name
University Medical Center Rotterdam Erasmus, Thoraxcentrum
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
American Heart of Poland Sp. z o.o.
City
Dąbrowa Górnicza
ZIP/Postal Code
43100
Country
Poland
Facility Name
Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern, Inselspital
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
University Hospital Zürich, Director of Invasive Cardiology, Rämistrasse 100
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Royal Brompton Hospital, Sydney Street
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

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18765162
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Limus Eluted From A Durable Versus ERodable Stent Coating

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