Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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