All-comer, Percutaneous Coronary Intervention
Conditions
Keywords
Biodegradable stents, converage, OCT
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.
Interventions
DEVICEDrug-eluting biodegradable stent Orsiro implantation
Drug-eluting biodegradable stent Orsiro implantation
DEVICEDrug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation
Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients ≥ 20 years old 2. Patients in the treatment of subjects with all-comer who are to undergo PCI
Exclusion criteria
1. Pregnant women or women with potential childbearing 2. Life expectancy \< 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neointimal coverage at 3 month after stent implantation | At 3 months after stent implantation | The percentage of stent uncoverage measured by optical coherence tomography |
Countries
South Korea
Outcome results
None listed