NCT03380286

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

3.8 years

First QC Date

December 17, 2017

Last Update Submit

March 7, 2018

Conditions

Coronary StenosisCoronary Disease

Keywords

FirehawkCoronary Artery DiseaseDrug Eluting Stent

Outcome Measures

Primary Outcomes (1)

  • Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)

    1 year

Secondary Outcomes (9)

  • All cause death

    5 year

  • Cardiac death

    5 year

  • Myocardial Infarction

    5 year

  • Composite event rate of death or myocardial infarction (MI)

    5 year

  • Composite event rate of cardiac death or myocardial infarction (MI)

    5 year

  • +4 more secondary outcomes

Study Arms (1)

Coronary Stenosis

Device: Firehawk

Interventions

FirehawkDEVICE

Firehawk stent

Coronary Stenosis

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with Firehawk® coronary stent

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary StenosisCoronary DiseaseCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Division of Cardiology

Study Record Dates

First Submitted

December 17, 2017

First Posted

December 21, 2017

Study Start

March 1, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2025

Last Updated

March 9, 2018

Record last verified: 2018-03

Locations

KR(1)