IRIS-Coroflex NEO Cohort (IRIS Coroflex)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Coronary Artery Stenosis
• Intervention / Treatment: Device: Coroflex ISAR NEO stent

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Jung-hee Ham, Project manager; Phone Number: 82230104728; Email: cvcrc5@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 138-736
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving Coroflex ISAR NEO stents.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coroflex ISAR NEO; Patients receiving percutaneous coronary intervention with Coroflex ISAR NEO stents	Device: Coroflex ISAR NEO stent; Percutaneous coronary intervention with Coroflex ISAR NEO stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the event rate of all cause death		5 years
the event rate of cardiac death		5 years
the event rate of Target- Vessel Revascularization (TVR)		5 years
the event rate of Target- lesion Revascularization (TLR)		5 years
the event rate of stent thrombosis	according to an Academic Research Consortium (ARC) criteria	5 years
the event rate of stroke		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 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
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

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: The CardioVascular Research Foundation (CVRF)

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Estimated): December 20, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Coronary Stenosis
• Other Study ID Numbers: AMCCV2023-05

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