Limus Eluted From A Durable Versus ERodable Stent Coating

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Disease, Coronary Stenosis

Intervention / Treatment
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* Device: Coronary stent placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BioMatrix Flex stent<br>Coronary stent placement with Biolimus A9 coated stent with biodegradable polymer | Device: Coronary stent placement<br>* Coronary stent placement<br>|
| Active Comparator: Cypher Select stent<br>Coronary stent placement with Sirolimus coated stent with durable polymer | Device: Coronary stent placement<br>* Coronary stent placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 30 days | 
| Cardiac death | Cardiac death | 30 days | 
| All deaths | All deaths (cardiac and non-cardiac) | 30 days | 
| Myocardial infarction | Myocardial infarction (Q-wave and NQWMI) | 30 days | 
| Angiographic and clinical stent thrombosis. | Angiographic and clinical stent thrombosis | 30 days | 
| In-stent and in-segment binary restenosis rate as assessed by QCA. | In-stent and in-segment binary restenosis rate as assessed by QCA. | 9 month | 
| 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 | 9 month | 
| In-segment percent diameter stenosis (%DS). | In-segment percent diameter stenosis (%DS) as assessed by QCA | 9 month | 
| In-stent and in-segment late luminal loss | In-stent and in-segment late luminal loss as assessed by QCA | 9 month | 
| Device success, lesion success and procedural success. |  | at implant | 
| 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) | 6 month | 
| 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) | 1 year | 
| 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) | 2 years | 
| Cardiac death | Cardiac death | 6 month | 
| Cardiac death | Cardiac death | 9 month | 
| Cardiac death | Cardiac death | 1 year | 
| Cardiac death | Cardiac death | 2 year | 
| Cardiac death | Cardiac death | 3 year | 
| Cardiac death | Cardiac death | 4 year | 
| Cardiac death | Cardiac death | 5 year | 
| 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) | 3 year | 
| 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) | 4 year | 
| 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) | 5 year | 
| All deaths | All deaths (cardiac and non-cardiac) | 6 month | 
| All deaths | All deaths (cardiac and non-cardiac) | 9 month | 
| All deaths | All deaths (cardiac and non-cardiac) | 1 year | 
| All deaths | All deaths (cardiac and non-cardiac) | 2 years | 
| All deaths | All deaths (cardiac and non-cardiac) | 3 years | 
| All deaths | All deaths (cardiac and non-cardiac) | 4 years | 
| All deaths | All deaths (cardiac and non-cardiac) | 5 years | 
| Myocardial infarction | Myocardial infarction (Q-wave and NQWMI) | 6 month | 
| Myocardial infarction | Myocardial infarction (Q-wave and NQWMI) | 9 month | 
| Myocardial infarction | Myocardial infarction (Q-wave and NQWMI) | 1 year | 
| Myocardial infarction | Myocardial infarction (Q-wave and NQWMI) | 2 years | 
| Myocardial infarction | Myocardial infarction (Q-wave and NQWMI) | 3 years | 
| Myocardial infarction | Myocardial infarction (Q-wave and NQWMI) | 4 years | 
| Myocardial infarction | Myocardial infarction (Q-wave and NQWMI) | 5 years | 
| Angiographic and clinical stent thrombosis. | Angiographic and clinical stent thrombosis | 6 month | 
| Angiographic and clinical stent thrombosis. | Angiographic and clinical stent thrombosis | 9 month | 
| Angiographic and clinical stent thrombosis. | Angiographic and clinical stent thrombosis | 1 year | 
| Angiographic and clinical stent thrombosis. | Angiographic and clinical stent thrombosis | 2 years | 
| Angiographic and clinical stent thrombosis. | Angiographic and clinical stent thrombosis | 3 years | 
| Angiographic and clinical stent thrombosis. | Angiographic and clinical stent thrombosis | 4 years | 
| Angiographic and clinical stent thrombosis. | Angiographic and clinical stent thrombosis | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Disease, Coronary Stenosis, Angioplasty, Coronary Restenosis, Drug Eluting Stent