Coronary Artery Disease, Drug Eluting Stent
Conditions
Brief summary
Observation of the safety and effectiveness of Cre8 stent, Cre8 evo stent in patients with ischemic heart disease with long coronary lesions
Detailed 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.
Interventions
DEVICECRE8 polymer-free Amphilimus-eluting stent, Cre8 evo stent
Percutaneous coronary intervention using a Cre8 stent, Cre8 evo stent for long lesions
Sponsors
Dio
Yonsei University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure including deaht, MI, ST, TLR | 12 months after the index procedure | number of Target lesion failure including deaht, MI, ST, TLR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death | 12 months after the index procedure | number of Cardiac death |
| Myocardial infarction | 12 months after the index procedure | number of Myocardial infarction |
| Stent thrombosis : definite or probable stent thrombosis by ARC definition | 12 months after the index procedure | number of Stent thrombosis |
| Target lesion revascularization | 12 months after the index procedure | number of Target lesion revascularization |
| All cause death | 12 months after the index procedure | number of All cause death |
| Stroke | 12 months after the index procedure | number of Stroke |
| BARC bleeding 2-5 | 12 months after the index procedure | number of BARC bleeding 2-5 |
| Stent overexpansion by OCT | immediately after the index procedure in hospitalization | Maximal stent diameter/ each diameter of stent |
| Target vessel revascularization | 12 months after the index procedure | number of Target vessel revascularization |
Countries
South Korea
Outcome results
None listed