IRIS Coroflex NEO stent registry

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

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 type: Observational
• Enrollment: 1000 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Asan Medical Center (Academic / other)
• Locations: 11 sites (Seoul, Songpa-gu and 10 other locations)
• Trial ID: NCT06177743 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Seoul, Songpa-gu and 10 other locations

• Asan Medical Center — Seoul, Songpa-gu, South Korea (Recruiting)
• Bucheon Sejong Hospital — Bucheon-si, South Korea (Not_yet_recruiting)
• The Catholic Univ. of Korea BUCHEON ST.Mary's hospital — Bucheon-si, South Korea (Not_yet_recruiting)
• Veterans Hospital — Daegu, South Korea (Recruiting)
• Chonnam National University Hospital — Gwangju, South Korea (Not_yet_recruiting)
• Inje University Ilsan Paik Hospital — Ilsan, South Korea (Not_yet_recruiting)
• Myongji Hospital — Ilsan, South Korea (Not_yet_recruiting)
• Sejong Chungnam National University Hospital — Sejong, South Korea (Recruiting)
• Seoul National University Boramae Medical Center — Seoul, South Korea (Not_yet_recruiting)
• The Catholic university of Korea, ST. Vincent's Hospital — Suwon, South Korea (Recruiting)
• Uijeongbu Eulji Medical Center — Uijeongbu-si, South Korea (Withdrawn)

Study contacts

• Study coordinator: Jung-Hee Ham, Project manager

Conditions Coronary Artery Stenosis; Coronary Artery Disease; percutaneous coronary intervention