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 type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 11 sites (Seoul, Songpa-gu and 10 other locations) |
| Status | Recruiting |
| Started | January 9, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2032 |
| Registry record updated | June 25, 2026 |
| Trial ID | NCT06177743 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
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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
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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
- Study coordinator: Jung-Hee Ham, Project manager
- Email: cvcrc5@amc.seoul.kr
- Phone: 82230104728
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.