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OpenTrials
Completed

NCT Number: NCT02084901

Comparison of Biodegradable Stents: Orsiro and BioMatrix

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.

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Key information

Conditions

All-comer Percutaneous Coronary Intervention

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seodaemun-gu, Shinchondong

Seoul, 120-752, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug-eluting biodegradable stent Orsiro implantation

Device

Drug-eluting biodegradable stent Orsiro implantation

Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation

Device

Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 12, 2014
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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