Actively Recruiting

Age: 19Years +
All Genders
ID06177743

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

Led by Seung-Jung Park · Updated on 2025-06-11

1000

Participants Needed

11

Research Sites

208 weeks

Total Duration

On this page

Sponsors

S

Seung-Jung Park

Lead Sponsor

T

The CardioVascular Research Foundation (CVRF)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Coroflex ISAR NEO stents in comparison to other drug-eluting stents for treating coronary artery stenosis and coronary artery disease in real-world clinical practice. This observational study aims to gather information on how well these stents perform and their safety profile over time. The study is led by Seung-Jung Park and involves patients undergoing percutaneous coronary intervention with the Coroflex ISAR NEO stent. Participants will receive treatment with the Coroflex ISAR NEO stent during their procedure. The study does not involve randomization or placebo groups, as it is an observational design focusing on patients treated with this specific stent device. Researchers will follow the patients after the procedure to observe outcomes and safety measures. During the study, participants will be monitored for events such as death, nonfatal myocardial infarction, and ischemic-driven target-vessel revascularization over 12 months. Additional outcomes include rates of all-cause death, cardiac death, myocardial infarction, target-lesion revascularization, stent thrombosis, stroke, and procedural success, observed over up to five years. Clinical follow-up schedules are part of the study protocol to collect these data and ensure patient safety throughout the observation period, which extends until the end of 2030.

CONDITIONS

Brief Title

IRIS-Coroflex NEO Cohort

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 19 years old or older
  • Patients receiving Coroflex ISAR NEO stents
  • Patient or guardian agrees to study protocol, follow-up schedule, and provides informed written consent approved by the Institutional Review Board/Ethics Committee
Not Eligible

You will not qualify if you...

  • Patients with a mixture of other drug-eluting stents
  • Terminal illness with life expectancy less than 1 year
  • Patients with cardiogenic shock

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of the procedure

Participants receive a Coroflex ISAR NEO stent through percutaneous coronary intervention as part of routine clinical practice.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored for safety and effectiveness outcomes including death, myocardial infarction, revascularization, and other cardiac events over time.

Follow-up visits according to routine clinical practice over 5 years

Trial Site Locations

Total: 11 locations

1

Asan Medical Center

Seoul, Songpa-gu, South Korea, 138-736

Actively Recruiting

2

Bucheon Sejong Hospital

Bucheon-si, South Korea

Not Yet Recruiting

3

The Catholic Univ. of Korea BUCHEON ST.Mary's hospital

Bucheon-si, South Korea

Not Yet Recruiting

4

Veterans Hospital

Daegu, South Korea

Actively Recruiting

5

Chonnam National University Hospital

Gwangju, South Korea

Not Yet Recruiting

6

Inje University Ilsan Paik Hospital

Ilsan, South Korea

Not Yet Recruiting

7

Myongji Hospital

Ilsan, South Korea

Not Yet Recruiting

8

Sejong Chungnam National University Hospital

Sejong, South Korea

Actively Recruiting

9

Seoul National University Boramae Medical Center

Seoul, South Korea

Not Yet Recruiting

10

The Catholic university of Korea, ST. Vincent's Hospital

Suwon, South Korea

Actively Recruiting

11

Uijeongbu Eulji Medical Center

Uijeongbu-si, South Korea

Withdrawn

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Research Team

J

Jung-Hee Ham, Project manager

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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