Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and safety of everolimus- and biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents. The null hypothesis to be rejected is that there is no significant difference with regard to lumen late loss at 9 months and a clinical end point of death, myocardial infarction and TVR at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting bioresorbable vascular scaffold stents.

Official Title
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Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Implantation of everolimus-eluting bioresorbable vascular scaffold stent
* Device: Implantation of everolimus-eluting stents
* Device: Implantation of biolimus-eluting stents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective PCI ability and willingness to provide written informed consent Exclusion Criteria: ST-elevation myocardial infarction in the previous 48 hours moderate to severe renal failure (defined as creatinine clearance of 30-60 ml/min and <30ml/min respectively) known or presumed hypersensitivity to heparin, antiplatelet drugs and hypersensitivity to contrast dye incontrollable with premedication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Everolimus-eluting bioresorbable vascular scaffold stents<br> | Device: Implantation of everolimus-eluting bioresorbable vascular scaffold stent<br> <br> |
| Active Comparator: Everolimus-eluting stent<br> | Device: Implantation of everolimus-eluting stents<br> <br> |
| Active Comparator: Biolimus-eluting stent<br> | Device: Implantation of biolimus-eluting stents<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumen Late Loss | as assessed by quantitative coronary angiogram | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-oriented major adverse cardiac events | The composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel) and target lesion revascularization | 6 months, 1, 2, 5 years | 
| Patient-oriented major adverse cardiac events | The composite of all-cause mortality, any myocardial infarction and any revascularization | 6 months, 1, 2, 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous coronary intervention, bioresorbable vascular scaffold stents, everolimus, biolimus