Coronary StenosisIRIS FirehawkNCT03380286
IRIS-Firehawk® Cohort in the IRIS-DES Registry
An observational study of Coronary Stenosis and Coronary Disease, run by Duk-Woo Park, MD at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Stenosis, Coronary Disease
- What is being tested?
- Firehawk
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2018to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Firehawk® coronary stent
Who may be able to join
- Age 19 and more
- Patient with Firehawk® coronary stent
Who cannot join
- Intervention with Firehawk® coronary stent and other drug eluting stent at the same time
- Life-expectancy less than 1 year
- Cardiac shock
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Effectiveness and Safety of Firehawk® Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
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.
- Conditions
- Coronary Stenosis, Coronary Disease
- Being tested
- Firehawk
- Keywords
- Firehawk, Coronary Artery Disease, Drug Eluting Stent
- Medical subject headings
- Coronary Stenosis, Coronary Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FirehawkDevice
Firehawk stent
| Study group | Role | What they receive |
|---|---|---|
| Coronary Stenosis | Not described Receives: Device: Firehawk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)
Measured: 1 year
Secondary outcomes (9)
All cause death
Measured: 5 year
Cardiac death
Measured: 5 year
Myocardial Infarction
Measured: 5 year
Composite event rate of death or myocardial infarction (MI)
Measured: 5 year
Composite event rate of cardiac death or myocardial infarction (MI)
Measured: 5 year
Target- Vessel Revascularization
Measured: 5 year
Target- Lesion Revascularization
Measured: 5 year
Stent thrombosis
Measured: 5 year
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.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study startMar 2018 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Funding issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duk-Woo Park, MD
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Duk-Woo Park, MD, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380286
- Sponsor's protocol ID
- AMCCV2017-09
- Acronym
- IRIS Firehawk
- Status last verified
- Mar 2018
- First submitted
- 17 Dec 2017
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Firehawk® Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03380286
- Acronym / sponsor ID
- IRIS Firehawk / AMCCV2017-09
- Conditions
- Coronary Stenosis, Coronary Disease
- Keywords
- Firehawk, Coronary Artery Disease, Drug Eluting Stent
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duk-Woo Park, MDUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- Mar 2018 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Stenosis | – | Device: Firehawk |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Firehawk® coronary stent
Key inclusion criteria (2 listed)
- Age 19 and more
- Patient with Firehawk® coronary stent
Key exclusion criteria (3 listed)
- Intervention with Firehawk® coronary stent and other drug eluting stent at the same time
- Life-expectancy less than 1 year
- Cardiac shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FirehawkFirehawk stent | Device | Coronary Stenosis |
Primary outcome
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)
Time frame: 1 year
9 secondary outcomes
All cause death
Time frame: 5 year
Cardiac death
Time frame: 5 year
Myocardial Infarction
Time frame: 5 year
Composite event rate of death or myocardial infarction (MI)
Time frame: 5 year
Composite event rate of cardiac death or myocardial infarction (MI)
Time frame: 5 year
Target- Vessel Revascularization
Time frame: 5 year
Target- Lesion Revascularization
Time frame: 5 year
Stent thrombosis
Time frame: 5 year
Procedural Success rate
Time frame: 5 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Stenosis and Coronary Disease, run by Duk-Woo Park, MD at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.