Comparison of the Biolimus A9-eluting Stent With the Zotarolimus -Eluting Stent in Multi-vessel PCI

Study Overview
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Brief Summary
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The risk of restenosis in the treatment of coronary artery disease has significantly lessened thanks to the introduction of Drug eluting stent. Yet, debates on the efficacy and safety of stents in complex lesions or patients have been circulated. Recently, PCI in multiple lesions is universally performed with the development of effective stents in various kinds in the clinics. However, a randomized study is rare for multi-vessel coronary artery disease in real procedural environments. The primary purpose of this study is to evaluate the clinical progress of biolimus A9-eluting stent and zotarolimus-eluting stent in multi-vessel coronary artery disease.

Detailed Description
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The patients who need multi-vessel stenting with multi-vessel coronary artery disease will be enrolled.Each randomization of the enrolled subjects will be done 1:1 (biolimus A9-eluting stent : zotarolimus-eluting stent). Randomization will be stratified by two factors: Diabetes mellitus and Acute coronary syndrome.Clinical follow-up will occur at the following time points; 1 month, 1 year and 2 years.

Official Title
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Prospective,Multicenter Study of Randomized Comparison of the Biolimus A9-eluting Stent With the Zotarolimus-eluting Stent in Multi-vessel PCI

Conditions
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Multivessel Coronary Artery Disease

Intervention / Treatment
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* Procedure: Percutaneous Coronary Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who need multi-vessel stenting with multi-vessel disease patients with signed informed consent Exclusion Criteria: known contraindication to any of the following medications: Aspirin,clopidogrel, heparin, contrast agent, Biolimus or Zotarolimus group Cardiogenic shock Pregnant women or women with potential childbearing End-stage diseases with life expectancy shorter than 2 years patients with other Drug eluting stents implanted Patients requiring modification of antiplatelet agents for planned major surgery within the first 12 months after the enrollment.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biolimus A9 eluting stent<br>biolimus A9 stent( Biomatrix or Biomatrix Flex) will be placed in under Percutaneous Coronary Intervention. | Procedure: Percutaneous Coronary Intervention<br>* Percutaneous Transluminal coronary angioplasty and Intervention will be performed in both of randomized groups of biolimus A9 eluting stent and zotarolimus eluting stent<br>* Other names: -Biomatrix Flex;|
| Active Comparator: Zotarolimus-eluting stent<br>zotarolimus eluting stent (Resolute Integrity) will be placed in under Percutaneous Coronary Intervention. | Procedure: Percutaneous Coronary Intervention<br>* Percutaneous Transluminal coronary angioplasty and Intervention will be performed in both of randomized groups of biolimus A9 eluting stent and zotarolimus eluting stent<br>* Other names: -Biomatrix Flex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year composite end points | All cause death, non fatal myocardial infarction, any revascularization | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death | All cause death | up to 2 years | 
| non-cardiac death | non-cardiac death | up to 2 years | 
| cardiac death | cardiac death | up to 2 years | 
| non fatal myocardial infarction | non fatal myocardial infarction | up to 2 years | 
| Any revascularization | Any revascularization | up to 2 years | 
| Target lesion revascularization | Target lesion revascularization | up to 2 years | 
| Target vessel revascularization | Target vessel revascularization | up to 2 years | 
| stent thrombosis | stent thrombosis | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multivessel stenting