Clinical trial NCT05658250: CREATE Trial, Prospective, Observational Study
Official title: Feasibility of CRE8 Polymer-free Amphilimus-eluting sTEnt in Patients With Diffuse Long Lesions (CREATE Trial): Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Drug Eluting Stent
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Dio
First posted: 2022-12-20
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 patients underwent Cre 8 stent, Cre8 evo stent implantation of 30 mm or more

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Target lesion failure including deaht, MI, ST, TLR
timeFrame: 12 months after the index procedure
Secondary outcomes:
measure: All cause death
timeFrame: 12 months after the index procedure
measure: Cardiac death
timeFrame: 12 months after the index procedure
measure: Myocardial infarction
timeFrame: 12 months after the index procedure
measure: Stent thrombosis : definite or probable stent thrombosis by ARC definition
timeFrame: 12 months after the index procedure
measure: Target lesion revascularization
timeFrame: 12 months after the index procedure
measure: Target vessel revascularization
timeFrame: 12 months after the index procedure
measure: Stroke
timeFrame: 12 months after the index procedure
measure: BARC bleeding 2-5
timeFrame: 12 months after the index procedure
measure: Stent overexpansion by OCT
timeFrame: immediately after the index procedure in hospitalization
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Gyeonggi-do
Study officials:
References: