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Active, not recruiting Observational

CREATE Trial, Prospective, Observational Study

NCT05658250 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2021-08-03
Last updated
2025-11-25

Condition(s) studied

Coronary Artery DiseaseDrug Eluting Stent

Investigational drug(s) / intervention(s)

CRE8 polymer-free Amphilimus-eluting stent, Cre8 evo stent

CRE8 polymer-free Amphilimus-eluting stent, Cre8 evo stent: Percutaneous coronary intervention using a Cre8 stent, Cre8 evo stent for long lesions

Study summary

Observation of the safety and effectiveness of Cre8 stent, Cre8 evo stent in patients with ischemic heart disease with long coronary lesions

Eligibility

Sex
ALL
Min age
19 Years
Max age
90 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. 19 years of age or older 2. Clinical evidence of coronary artery disease, including asymptomatic ischemia, stable angina, and acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction, ST-segment elevation myocardial infarction) 3. Coronary artery lesion length 30 mm or more 4. Those who voluntarily agreed in writing to participate in this clinical study Exclusion Criteria: 1. Remaining life expectancy is less than 1 year 2. Subjects with known hypersensitivity or contraindication to the following drugs or substances: heparin, aspirin, clopidogrel, prasugrel, ticagrelor 3. In case the other researcher judges that it is inappropriate to participate in this study (pregnant women, the elderly, etc.)

Primary outcome measure(s)

  • Target lesion failure including deaht, MI, ST, TLR — 12 months after the index procedure
    number of Target lesion failure including deaht, MI, ST, TLR

Trial sites (1)

FacilityCityRegionStatus
Yongin Severance Hospital Yongin Gyeonggi-do
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05658250 on ClinicalTrials.gov ↗ ← All trials in South Korea