IRIS-Firehawk® Cohort in the IRIS-DES Registry | NCT03380286

Studies
IRIS-Firehawk® Cohort in the IRIS-DES Registry

NCT03380286

Sponsor

Duk-Woo Park, MD

Status

Withdrawn

Last Update Posted

Mar 9, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Coronary Stenosis
Coronary Disease

Interventions

Firehawk

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding issue

Expanded Access Info

Start Date

Mar 2018Estimated

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Dec 17, 2017

First Submission Date that Met QC Criteria

Dec 17, 2017

First Posted Date

Dec 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2018

Last Update Posted Date

Mar 9, 2018Actual

Name	Class
CardioVascular Research Foundation, Korea	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Coronary Stenosis			Device: Firehawk

Name	Type	Description	Arm Group Labels	Other Names
Firehawk	Device	Firehawk stent	Coronary Stenosis

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
All cause death		5 year
Cardiac death		5 year
Myocardial Infarction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with Firehawk® coronary stent

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D023921	Coronary Stenosis
D003327	Coronary Disease
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided