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IRIS-Firehawk® Cohort in the IRIS-DES Registry

Evaluation of Effectiveness and Safety of Firehawk® Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03380286
Acronym
IRIS Firehawk
Enrollment
0
Registered
2017-12-21
Start date
2018-03-31
Completion date
2025-12-31
Last updated
2018-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease, Coronary Stenosis

Keywords

Firehawk, Coronary Artery Disease, Drug Eluting Stent

Brief summary

The objective of this study is to evaluate effectiveness and safety of Firehawk® stent in the real world daily practice as compared with other drug-eluting stents.

Interventions

DEVICEFirehawk

Firehawk stent

Sponsors

CardioVascular Research Foundation, Korea
CollaboratorOTHER
Duk-Woo Park, MD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 19 and more * Patient with Firehawk® coronary stent

Exclusion criteria

* Intervention with Firehawk® coronary stent and other drug eluting stent at the same time * Life-expectancy less than 1 year * Cardiac shock

Design outcomes

Primary

MeasureTime frame
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)1 year

Secondary

MeasureTime frameDescription
Cardiac death5 year
Myocardial Infarction5 year
Composite event rate of death or myocardial infarction (MI)5 year
Composite event rate of cardiac death or myocardial infarction (MI)5 year
All cause death5 year
Target- Lesion Revascularization5 year
Stent thrombosis5 year
Procedural Success rate5 yearProcedural success rate is defined as \< 30% final stenosis and the absence of in-hospital event including death, Q wave myocardial infarction, urgent repeat revascularization.
Target- Vessel Revascularization5 year

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026