Comparison of Biodegradable Stents: Orsiro and BioMatrix

Phase 4

Completed

• Conditions: Percutaneous Coronary Intervention; All-comer
• Interventions: Device: Drug-eluting biodegradable stent Orsiro implantation; Device: Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation

• Registration Number: NCT02084901
• Lead Sponsor: Yonsei University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-09
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-12
• Primary Completion: 2015-03
• Study Completion: 2016-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Patients ≥ 20 years old
2. Patients in the treatment of subjects with all-comer who are to undergo PCI

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Exclusion Criteria

1. Pregnant women or women with potential childbearing
2. Life expectancy < 1 year

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orsiro Arm	Drug-eluting biodegradable stent Orsiro implantation	-
BioMatrix or BioMatrix Flex Arm	Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation	-

Primary Outcome Measures

Name	Time	Method
Neointimal coverage at 3 month after stent implantation	At 3 months after stent implantation	The percentage of stent uncoverage measured by optical coherence tomography

Trial Locations

Locations (1)

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seodaemun-gu, Shinchondong; 🇰🇷 Seoul, Korea, Republic of