CREATE Trial, Prospective, Observational Study

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05658250
• Other study ID #: 9-2021-0093
• Status: Recruiting
• Start date: August 3, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Yonsei University
• Contact: deok kyu CHO, MD
• Phone: +82-31-5189-8755
• Email: CHODK123[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Drug Eluting Stent

Intervention

Device:
• CRE8 polymer-free Amphilimus-eluting stent, Cre8 evo stent
Percutaneous coronary intervention using a Cre8 stent, Cre8 evo stent for long lesions

Locations

Country	Name	City	State
Korea, Republic of	Yongin Severance Hospital	Yongin	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	Dio

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure including deaht, MI, ST, TLR	number of Target lesion failure including deaht, MI, ST, TLR	12 months after the index procedure
Secondary	All cause death	number of All cause death	12 months after the index procedure
Secondary	Cardiac death	number of Cardiac death	12 months after the index procedure
Secondary	Myocardial infarction	number of Myocardial infarction	12 months after the index procedure
Secondary	Stent thrombosis : definite or probable stent thrombosis by ARC definition	number of Stent thrombosis	12 months after the index procedure
Secondary	Target lesion revascularization	number of Target lesion revascularization	12 months after the index procedure
Secondary	Target vessel revascularization	number of Target vessel revascularization	12 months after the index procedure
Secondary	Stroke	number of Stroke	12 months after the index procedure
Secondary	BARC bleeding 2-5	number of BARC bleeding 2-5	12 months after the index procedure
Secondary	Stent overexpansion by OCT	Maximal stent diameter/ each diameter of stent	immediately after the index procedure in hospitalization