CREATE Trial, Prospective, Observational Study
Feasibility of CRE8 Polymer-free Amphilimus-eluting sTEnt in Patients With Diffuse Long Lesions (CREATE Trial): Prospective, Observational Study
1 other identifier
observational
300
1 country
1
Brief Summary
Observation of the safety and effectiveness of Cre8 stent, Cre8 evo stent in patients with ischemic heart disease with long coronary lesions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 3, 2021
CompletedFirst Submitted
Initial submission to the registry
December 12, 2022
CompletedFirst Posted
Study publicly available on registry
December 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
November 25, 2025
November 1, 2025
6.4 years
December 12, 2022
November 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
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
Stent thrombosis : definite or probable stent thrombosis by ARC definition
12 months after the index procedure
Target lesion revascularization
12 months after the index procedure
- +4 more secondary outcomes
Interventions
Percutaneous coronary intervention using a Cre8 stent, Cre8 evo stent for long lesions
Eligibility Criteria
300 patients underwent Cre 8 stent, Cre8 evo stent implantation of 30 mm or more
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yonsei Universitylead
- Diocollaborator
Study Sites (1)
Yongin Severance Hospital
Yongin, Gyeonggi-do, 16995, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 12, 2022
First Posted
December 20, 2022
Study Start
August 3, 2021
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
November 25, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share