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Biofreedom Prospective Multicenter Observational Registry

NCT03045848 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 194

Last updated 2021-05-13

No results posted yet for this study

Summary

LEADERS-FREE trial demonstrated the safety and efficacy of polymer-free drug-coated stent (Biofreedom, Biosensors International Technologies, Singapore) in patients with high bleeding risk. But, there are limited clinical evidences for extending these findings to generalized patients who are eligible to PCI. Therefore, the purpose of this registry is to evaluate the safety and efficacy of Biofreedom stent in patients with coronary artery disease.

Conditions

Interventions

DEVICE

Biofreedom drug-coated stent

BioFreedom (Biosensors International Technologies, Singapore) is the only polymer- and carrier-free drug coated stent with Biolimus A9 in a selectively micro-structured abluminal surface. It is a stainless steel bare metal surface with 120 micron thick corrugated ring strut.

Sponsors & Collaborators

  • Cordis Corporation

    collaborator INDUSTRY

  • Wonju Severance Christian Hospital

    lead OTHER

Principal Investigators

  • Junghan Yoon, MD, PhD · Yonsei University

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-05
Primary Completion
2020-06-30
Completion
2020-11-10

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT03045848 on ClinicalTrials.gov