Comparison of Biodegradable Stents: Orsiro and BioMatrix
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- All-comer
- Sponsor
- Yonsei University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Neointimal coverage at 3 month after stent implantation
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Neointimal coverage at 3 month after stent implantation
Time Frame: At 3 months after stent implantation
The percentage of stent uncoverage measured by optical coherence tomography