Comparison of Biodegradable Stents: Orsiro and BioMatrix
NCT ID: NCT02084901
Last Updated: 2016-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
12 participants
INTERVENTIONAL
2014-03-31
2016-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Orsiro Arm
Drug-eluting biodegradable stent Orsiro implantation
Drug-eluting biodegradable stent Orsiro implantation
BioMatrix or BioMatrix Flex Arm
Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation
Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation
Interventions
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Drug-eluting biodegradable stent Orsiro implantation
Drug-eluting biodegradable stent Orsiro implantation
Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation
Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation
Eligibility Criteria
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Inclusion Criteria
2. Patients in the treatment of subjects with all-comer who are to undergo PCI
Exclusion Criteria
2. Life expectancy \< 1 year
20 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seodaemun-gu, Shinchondong
Seoul, , South Korea
Countries
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Other Identifiers
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1-2013-0083
Identifier Type: -
Identifier Source: org_study_id
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