IRIS-Coroflex NEO Cohort

Coronary Artery Disease Clinical Trial

— IRIS Coroflex  

Official title:

Evaluation of Effectiveness and Safety of Coroflex ISAR NEO Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06177743
• Other study ID #: AMCCV2023-05
• Status: Not yet recruiting
• Start date: January 31, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: December 2023
• Source: Asan Medical Center
• Contact: Jung-Hee Ham, Project manager
• Phone: 82230104728
• Email: cvcrc5[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The objective of this study is to evaluate the effectiveness and safety of Coroflex ISAR NEO stents in comparison to other drug-eluting stents (DES) in real-world practice.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Patients = 19 years old

2. Patients receiving Coroflex ISAR NEO stents.

3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

1. Patients with a mixture of other DESs

2. Terminal illness with life expectancy <1 year.

3. Patients with cardiogenic shock

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

Device:
• Coroflex ISAR NEO stent
Percutaneous coronary intervention with Coroflex ISAR NEO stent

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	The CardioVascular Research Foundation (CVRF)

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)	the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post procedure.; A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.	12 months
Secondary	the event rate of all cause death		5 years
Secondary	the event rate of cardiac death		5 years
Secondary	the event rate of myocardial infarction		5 years
Secondary	the composite event rate of death, or myocardial infarction (MI)		5 years
Secondary	the composite event rate of cardiac death, or myocardial infarction (MI)		5 years
Secondary	the event rate of Target- Vessel Revascularization (TVR)		5 years
Secondary	the event rate of Target- lesion Revascularization (TLR)		5 years
Secondary	the event rate of stent thrombosis	according to an Academic Research Consortium (ARC) criteria	5 years
Secondary	the event rate of stent thrombosis	Procedural success (defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization).	5 years
Secondary	the event rate of stroke		5 years
Secondary	the event rate of Procedural success	defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization.	5 days