Comparison of Biodegradable Stents: Orsiro and BioMatrix

Yonsei University

Status and phase: Completed; Phase 4

Conditions: All-comer; Percutaneous Coronary Intervention

Treatments: Device: Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation; Device: Drug-eluting biodegradable stent Orsiro implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02084901

1-2013-0083

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Orsiro Arm

Experimental group

Treatment:

Device: Drug-eluting biodegradable stent Orsiro implantation

BioMatrix or BioMatrix Flex Arm

Active Comparator group

Treatment:

Device: Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation