IRIS-Coroflex NEO Cohort (IRIS Coroflex)

June 10, 2025 updated by: Seung-Jung Park

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Not yet recruiting
        • Bucheon Sejong Hospital
        • Principal Investigator:
          • Ha-wook Park, MD
        • Contact:
          • Ha-wook Park, MD
      • Bucheon, Korea, Republic of
        • Not yet recruiting
        • The Catholic Univ. of Korea BUCHEON ST.Mary's hospital
        • Contact:
          • Dong-bin Kim, MD
        • Principal Investigator:
          • Dong-bin Kim, MD
      • Daegu, Korea, Republic of
        • Recruiting
        • Veterans Hospital
        • Contact:
          • Sang-wook Kang, MD
        • Principal Investigator:
          • Sang-wook Kang, MD
      • Gwangju, Korea, Republic of
        • Not yet recruiting
        • Chonnam National University Hospital
        • Contact:
          • Young-joon Hong, MD
        • Principal Investigator:
          • Young-joon Hong, MD
      • Ilsan, Korea, Republic of
        • Not yet recruiting
        • Inje University Ilsan Paik Hospital
        • Contact:
          • Joon-hyung Do, MD
        • Principal Investigator:
          • Joon-hyung Do, MD
      • Ilsan, Korea, Republic of
        • Not yet recruiting
        • Myongji Hospital
        • Contact:
          • Yoon-Hyoung Cho, MD
        • Principal Investigator:
          • Yoon-Hyoung Cho, MD
      • Sejong, Korea, Republic of
        • Recruiting
        • Sejong Chungnam National University Hospital
        • Contact:
          • Jae-Hyung No, MD
        • Principal Investigator:
          • Jae-Hyung No, MD
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Seoul National University Boramae Medical Center
        • Contact:
          • Sang-hyun Kim, MD
        • Principal Investigator:
          • Sang-hyun Kim, MD
      • Suwon, Korea, Republic of
        • Recruiting
        • The Catholic university of Korea, St. Vincent's Hospital
        • Contact:
          • Dong-kyu Moon, MD
        • Principal Investigator:
          • Dong-kyu Moon, MD
      • Uijeongbu, Korea, Republic of
        • Withdrawn
        • Uijeongbu Eulji Medical Center
    • Songpa-gu
      • Seoul, Songpa-gu, Korea, Republic of, 138-736
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Seung-jung Park, MD, PhD
        • Principal Investigator:
          • Seung-jung Park, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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)
Time Frame: 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.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seung-Jung Park

Collaborators

The CardioVascular Research Foundation (CVRF)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2025

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 (Actual)

December 20, 2023

Study Record Updates

Last Update Posted (Actual)

June 11, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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