IRIS-Firehawk® Cohort in the IRIS-DES Registry (IRIS Firehawk)

March 7, 2018 updated by: Duk-Woo Park, MD

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient with Firehawk® coronary stent

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary Stenosis
Device: Firehawk
Firehawk stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duk-Woo Park, MD

Collaborators

CardioVascular Research Foundation, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

December 17, 2017

First Submitted That Met QC Criteria

December 17, 2017

First Posted (ACTUAL)

December 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 7, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV2017-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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