IRIS-Coroflex NEO Cohort

Not yet recruiting

• Conditions: Coronary Artery Stenosis; Coronary Artery Disease
• Interventions: Device: Coroflex ISAR NEO stent

• Registration Number: NCT06177743
• Lead Sponsor: Seung-Jung Park

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-11
• Study First Posted: 2023-12-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Study Start: 2025-02-01
• Primary Completion: 2026-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coroflex ISAR NEO	Coroflex ISAR NEO stent	Patients receiving percutaneous coronary intervention with Coroflex ISAR NEO stents

Primary Outcome Measures

Name	Time	Method
the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
the event rate of Target- lesion Revascularization (TLR)	5 years
the event rate of stent thrombosis	5 years	according to an Academic Research Consortium (ARC) criteria
the event rate of stroke	5 years
the event rate of all cause death	5 years
the event rate of cardiac death	5 years
the event rate of myocardial infarction	5 years
the composite event rate of death, or myocardial infarction (MI)	5 years
the composite event rate of cardiac death, or myocardial infarction (MI)	5 years
the event rate of Target- Vessel Revascularization (TVR)	5 years
the event rate of Procedural success	5 days	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.

Trial Locations

Locations (11)

Bucheon Sejong Hospital; 🇰🇷 Bucheon, Korea, Republic of

The Catholic Univ. of Korea BUCHEON ST.Mary's hospital; 🇰🇷 Bucheon, Korea, Republic of

Veterans Hospital; 🇰🇷 Daegu, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Inje University Ilsan Paik Hospital; 🇰🇷 Ilsan, Korea, Republic of

Myongji Hospital; 🇰🇷 Ilsan, Korea, Republic of

Sejong Chungnam National University Hospital; 🇰🇷 Sejong, Korea, Republic of

Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic university of Korea, ST. Vincent's Hospital; 🇰🇷 Suwon, Korea, Republic of

Uijeongbu Eulji Medical Center; 🇰🇷 Uijeongbu, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of