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

• Sponsor: Duk-Woo Park, MD (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03380286
• Collaborator: CardioVascular Research Foundation, Korea (Other)
• Enrollment: 0
• Location: 1
• Anticipated Duration (Months): 93
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Stenosis; Coronary Disease	Device: Firehawk

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Effectiveness and Safety of Firehawk® Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
• Anticipated Study Start Date: Mar 1, 2018
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Coronary Stenosis	Device: Firehawk; Firehawk stent

Outcome Measures

Primary Outcome Measures

1. Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) [1 year]

Secondary Outcome Measures

1. All cause death [5 year]

2. Cardiac death [5 year]

3. Myocardial Infarction [5 year]

4. Composite event rate of death or myocardial infarction (MI) [5 year]

5. Composite event rate of cardiac death or myocardial infarction (MI) [5 year]

6. Target- Vessel Revascularization [5 year]

7. Target- Lesion Revascularization [5 year]

8. Stent thrombosis [5 year]

9. Procedural Success rate [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Duk-Woo Park, MD
• CardioVascular Research Foundation, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duk-Woo Park, MD, Professor, Division of Cardiology, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT03380286
• Other Study ID Numbers: AMCCV2017-09
• First Posted: Dec 21, 2017
• Last Update Posted: Mar 9, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Duk-Woo Park, MD, Professor, Division of Cardiology, Asan Medical Center: Firehawk; Coronary Artery Disease; Drug Eluting Stent
• Additional relevant MeSH terms: Coronary Disease; Coronary Stenosis

Study Results

No Results Posted as of Mar 9, 2018