Coronary Disease Clinical Trial
— IRIS FirehawkOfficial title:
Evaluation of Effectiveness and Safety of Firehawk® Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Verified date | March 2018 |
Source | Asan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Duk-Woo Park, MD | CardioVascular Research Foundation, Korea |
Korea, Republic of,
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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