CREATE Trial, Prospective, Observational Study

Yonsei University

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Drug Eluting Stent

Treatments: Device: CRE8 polymer-free Amphilimus-eluting stent, Cre8 evo stent

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05658250

9-2021-0093

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 19 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.)