IRIS-Firehawk® Cohort in the IRIS-DES Registry

Withdrawn

• Conditions: Coronary Stenosis; Coronary Disease
• Interventions: Device: Firehawk

• Registration Number: NCT03380286
• Lead Sponsor: Duk-Woo Park, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-17
• Study First Submitted QC: 2017-12-17
• Study First Posted: 2017-12-21
• Status Verified: 2018-03
• Study Start: 2018-03
• Last Update Submitted: 2018-03-07
• Last Update Posted: 2018-03-09
• Primary Completion: 2021-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary Stenosis	Firehawk	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Composite event rate of death or myocardial infarction (MI)	5 year
Stent thrombosis	5 year
Procedural Success rate	5 year	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.
All cause death	5 year
Composite event rate of cardiac death or myocardial infarction (MI)	5 year
Target- Vessel Revascularization	5 year
Target- Lesion Revascularization	5 year
Cardiac death	5 year
Myocardial Infarction	5 year

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of