CREATE Trial, Prospective, Observational Study

Recruiting

• Conditions: Coronary Artery Disease; Drug Eluting Stent

• Registration Number: NCT05658250
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2021-08-03
• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-19
• Study First Posted: 2022-12-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
All cause death	12 months after the index procedure	number of All cause death
Cardiac death	12 months after the index procedure	number of Cardiac death
Myocardial infarction	12 months after the index procedure	number of Myocardial infarction
Target lesion revascularization	12 months after the index procedure	number of Target lesion revascularization
Stroke	12 months after the index procedure	number of Stroke
Stent thrombosis : definite or probable stent thrombosis by ARC definition	12 months after the index procedure	number of Stent thrombosis
Target vessel revascularization	12 months after the index procedure	number of Target vessel revascularization
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

Trial Locations

Locations (1)

Yongin Severance Hospital; 🇰🇷 Yongin, Gyeonggi-do, Korea, Republic of