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Comparison of Biodegradable Stents: Orsiro and BioMatrix

NCT02084901 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-07-27

No results posted yet for this study

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.

Conditions

  • All-comer
  • Percutaneous Coronary Intervention

Interventions

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-03-31
Completion
2016-03-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02084901 on ClinicalTrials.gov