Feasibility of CRE8 Polymer-free Amphilimus-eluting sTEnt in Patients With Diffuse Long Lesions (CREATE Trial): Prospective, Observational Study

Yonsei University1 site in 1 country300 target enrollmentAugust 3, 2021

ConditionsCoronary Artery Disease Drug Eluting Stent

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Yonsei University
Enrollment: 300
Locations: 1
Primary Endpoint: Target lesion failure including deaht, MI, ST, TLR
Status: Active, not recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 3, 2021

End Date

December 31, 2027

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Yonsei University

Responsible Party

Principal Investigator

Deok-Kyu Cho

Professor

Yonsei University

Eligibility Criteria

Inclusion Criteria

•19 years of age or older
•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)
•Coronary artery lesion length 30 mm or more
•Those who voluntarily agreed in writing to participate in this clinical study

Exclusion Criteria

•Remaining life expectancy is less than 1 year
•Subjects with known hypersensitivity or contraindication to the following drugs or substances: heparin, aspirin, clopidogrel, prasugrel, ticagrelor
•In case the other researcher judges that it is inappropriate to participate in this study (pregnant women, the elderly, etc.)

Outcomes

Primary Outcomes

Target lesion failure including deaht, MI, ST, TLR

Time Frame: 12 months after the index procedure

number of Target lesion failure including deaht, MI, ST, TLR

Secondary Outcomes

All cause death(12 months after the index procedure)
Cardiac death(12 months after the index procedure)
Myocardial infarction(12 months after the index procedure)
Target lesion revascularization(12 months after the index procedure)
Stroke(12 months after the index procedure)
Stent thrombosis : definite or probable stent thrombosis by ARC definition(12 months after the index procedure)
Target vessel revascularization(12 months after the index procedure)
BARC bleeding 2-5(12 months after the index procedure)
Stent overexpansion by OCT(immediately after the index procedure in hospitalization)