Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents

Study Overview
=================
Brief Summary
-----------------
To compare the safety and efficacy of coronary stenting with everolimus-eluting stent (Promus Element®) and biolimus-eluting stent with biodegradable polymer (Nobori®)

Official Title
-----------------
Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Promus Element, Boston Scientific Corporation
* Device: Nobori, Terumo Corporation (Japan)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Significant coronary artery stenosis (> 50% by visual estimate) Stable angina, unstable angina, Non-ST elevation myocardial infarction (NSTEMI) and documented silent ischemia Patients eligible for intracoronary stenting age ≥ 20 years old Exclusion Criteria: ST segment elevation myocardial infarction (within 24 hours) Low ejection fraction (< 25%) Cardiogenic shock History of bleeding diathesis or known coagulopathy Limited life-expectancy (less than 1 year) due to combined serious disease Contraindication to heparin, sirolimus, everolimus and biolimus Contraindication to aspirin and clopidogrel Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Promus Element<br>Everolimus-eluting stent | Device: Promus Element, Boston Scientific Corporation<br>* Everolimus-eluting stent<br>* Other names: Everolimus-eluting stent;|
| Active Comparator: Nobori<br>Biolimus-eluting stent with biodegradable polymer | Device: Nobori, Terumo Corporation (Japan)<br>* Biolimus-eluting stent with biodegradable polymer<br>* Other names: Biolimus-eluting stent with biodegradable polymer;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis |  | 1 year after index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with majour adverse cardiac events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis |  | 2 years after index procedure | 
| Death (all-cause and cardiac) |  | 1 to 2 years after index procedure | 
| Myocardial infarction (Q wave and non-Q wave) |  | 1 to 2 years after index procedure | 
| Target vessel revascularization (ischemia- and clinically-driven) |  | 1 to 2 years after index procedure | 
| Target lesion revascularization (ischemia- and clinically-driven) |  | 1 to 2 years after index procedure | 
| Stent thrombosis |  | 1 to 2 years after index procedure | 
| In-stent and in-segment late loss at 1 year angiographic follow-up |  | 1 year after index procedure | 
| In-stent and in-segment restenosis at 1 year angiographic follow-up |  | 1 year after index procedure | 
| Incidence and angiographic pattern of restenosis at 1 year angiographic follow-up |  | 1 year after index procedure | 
| The incidence of Procedural success |  | index procedure (day 0) | 
| The number of participants with death and myocardial infarction |  | 1 to 2 years after index procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery disease, Stent