A Phase 4 interventional study of Drug-eluting biodegradable stent Orsiro implantation and Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation in All-comer and Percutaneous Coronary Intervention, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-07-27.
Sponsored by Yonsei University · Phase 4, Interventional, and Treatment
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.
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.
Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Drug-eluting biodegradable stent Orsiro implantation
Device: Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation
Drug-eluting biodegradable stent Orsiro implantation
Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation
Neointimal coverage at 3 month after stent implantation
The percentage of stent uncoverage measured by optical coherence tomography
Time frame: At 3 months after stent implantation
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Yonsei University