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NCT03380286 Clinical Trial

IRIS-Firehawk® Cohort in the IRIS-DES Registry

Coronary Disease Clinical Trial

— IRIS Firehawk  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03380286
Other study ID # AMCCV2017-09
Secondary ID
Status Withdrawn
Phase N/A
First received December 17, 2017
Last updated March 7, 2018
Start date March 2018
Est. completion date December 2025

Study information
Verified date March 2018
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2025
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Firehawk
Firehawk stent

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (2)
Lead Sponsor Collaborator
Duk-Woo Park, MD CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) 1 year
Secondary All cause death 5 year
Secondary Cardiac death 5 year
Secondary Myocardial Infarction 5 year
Secondary Composite event rate of death or myocardial infarction (MI) 5 year
Secondary Composite event rate of cardiac death or myocardial infarction (MI) 5 year
Secondary Target- Vessel Revascularization 5 year
Secondary Target- Lesion Revascularization 5 year
Secondary Stent thrombosis 5 year
Secondary Procedural Success rate Procedural success rate is defined as < 30% final stenosis and the absence of in-hospital event including death, Q wave myocardial infarction, urgent repeat revascularization. 5 year
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