Clinical trial Recruiting at 7 sites Observational Ages 19 and up

IRIS Coroflex NEO stent registry

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

Run by Asan Medical Center · NCT06177743 · Data updated 2026-11-12

This project tests whether Coroflex ISAR NEO drug-eluting stents are safe and work well for adults having percutaneous coronary intervention for coronary artery disease.

Quick facts

Study typeObservational
Ages19 Years and up
SexAll
Enrollment1000 (estimated)
SponsorAsan Medical Center
Academic / other
Locations11 sites (Seoul, Songpa-gu and 10 other locations)
StatusRecruiting
StartedJanuary 9, 2025
Main results expectedDecember 31, 2028
Study endsDecember 31, 2032
Registry record updatedJune 25, 2026
Trial IDNCT06177743 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥19 years) undergoing PCI who receive a Coroflex ISAR NEO stent, can provide informed consent, and are not treated with mixed DES or in cardiogenic shock are ideal candidates.

Probably not a fit

Patients who receive a mixture of different drug-eluting stents, are in cardiogenic shock, or have a terminal illness with life expectancy under one year are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, multicenter registry follows adults who receive the Coroflex ISAR NEO drug-eluting stent during routine percutaneous coronary interventions and compares outcomes with other contemporary DES in real-world practice. Patients aged 19 or older who receive the Coroflex stent and consent to scheduled clinical follow-up are enrolled, while those receiving mixed DES types, in cardiogenic shock, or with life expectancy under one year are excluded. Clinical outcomes such as device-related complications, restenosis, and major adverse cardiac events are recorded during follow-up visits at participating South Korean centers. Data will be analyzed descriptively to characterize safety and effectiveness in routine clinical care rather than under randomized conditions.

Why it matters

Potential benefit: If successful, the registry could show that Coroflex ISAR NEO provides comparable or improved safety and effectiveness versus other DES, helping clinicians choose stents.

How similar studies have gone: Other registries and trials of drug-eluting stents have shown improved outcomes versus older devices, but device-specific clinical evidence for Coroflex ISAR NEO is more limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Asan Medical Center
    Seoul, Songpa-gu, South Korea
    Recruiting
  • Bucheon Sejong Hospital
    Bucheon-si, South Korea
    Recruiting
  • The Catholic Univ. of Korea BUCHEON ST.Mary's hospital
    Bucheon-si, South Korea
    Recruiting
  • Veterans Hospital
    Daegu, South Korea
    Recruiting
  • Myongji Hospital
    Ilsan, South Korea
    Recruiting
  • Sejong Chungnam National University Hospital
    Sejong, South Korea
    Recruiting
Show 5 more locations
  • The Catholic university of Korea, ST. Vincent's Hospital
    Suwon, South Korea
    Recruiting
  • Chonnam National University Hospital
    Gwangju, South Korea
    Not yet recruiting
  • Inje University Ilsan Paik Hospital
    Ilsan, South Korea
    Not yet recruiting
  • Seoul National University Boramae Medical Center
    Seoul, South Korea
    Not yet recruiting
  • Uijeongbu Eulji Medical Center
    Uijeongbu-si, South Korea
    Withdrawn

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.