Comparison of Biodegradable Stents: Orsiro and BioMatrix

Study Overview
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Brief Summary
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The use of a biodegradable polymer has the potential to reduce the sustained inflammatory response of the arterial wall, facilitating re-endothelialization and minimizing the risk of thrombus formation and late restenosis. In the study, we are going to two biodegradable polymer stents, Orsiro and BioMatrix, especially regarding the stent strut coverage by optical coherence tomography at 3 months after stent implantation. The primary objective of this study is to test the hypothesis that Orsiro is non-inferior to Biomatrix in terms of stent strut coverage by optical coherence tomography at 3 months. The secondary endpoint is clinical outcomes up to 1 year.

Detailed Description
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The use of a biodegradable polymer has the potential to reduce the sustained inflammatory response of the arterial wall, facilitating re-endothelialization and minimizing the risk of thrombus formation and late restenosis. In the study, we are going to two biodegradable polymer stents, Orsiro and BioMatrix, especially regarding the stent strut coverage by optical coherence tomography at 3 months after stent implantation. The primary objective of this study is to test the hypothesis that Orsiro is non-inferior to Biomatrix in terms of stent strut coverage by optical coherence tomography at 3 months. The secondary endpoint is clinical outcomes up to 1 year.

Official Title
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Comparison of Biodegradable Stents: Orsiro and BioMatrix

Conditions
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All-comer, Percutaneous Coronary Intervention

Intervention / Treatment
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* Device: Drug-eluting biodegradable stent Orsiro implantation
* Device: Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 20 years old Patients in the treatment of subjects with all-comer who are to undergo PCI Exclusion Criteria: Pregnant women or women with potential childbearing Life expectancy < 1 year

Ages Eligible for Study
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Minimum Age: 20 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: Orsiro Arm<br> | Device: Drug-eluting biodegradable stent Orsiro implantation<br>* Drug-eluting biodegradable stent Orsiro implantation<br>|
| Active Comparator: BioMatrix or BioMatrix Flex Arm<br> | Device: Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation<br>* Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neointimal coverage at 3 month after stent implantation | The percentage of stent uncoverage measured by optical coherence tomography | At 3 months after stent implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biodegradable stents, converage, OCT