NCT02084901

Comparison of Biodegradable Stents: Orsiro and BioMatrix

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• All-comer
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DEVICE	Drug-eluting biodegradable stent Orsiro implantation	Drug-eluting biodegradable stent Orsiro implantation
DEVICE	Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation	Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-03-01
• Completion: 2016-03-01
• First posted: 2014-03-12
• Last updated: 2016-07-27

Locations

1 site across 1 country: South Korea