CREATE Trial, Prospective, Observational Study

N/AActive Not RecruitingNCT05658250

Yonsei University300 enrolled

Overview

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

The purpose of this study is to observe the prognosis of 300 patients with long lesions over 30 mm treated with a new-generation Cre8 stent, Cre8 evo stent that is polymer-free and releases fat-soluble ampilimus in the real world. In addition, in the case of inserting a 46mm very long stent through sub-analysis, we also want to check whether stent expansion is performed through OCT rather than IVUS.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Coronary Artery Disease Drug Eluting Stent

Interventions

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

Percutaneous coronary intervention using a Cre8 stent, Cre8 evo stent for long lesions

Eligibility

Sex: ALLMin age: 19 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.)

Locations (1)

Yongin Severance Hospital

Yongin, Gyeonggi-do, South Korea