Coronary Artery DiseaseNCT05658250
CREATE Trial, Prospective, Observational Study
An observational study of Coronary Artery Disease and Drug Eluting Stent, run by Yonsei University at 1 site in South Korea.
Trial summary
Observation of the safety and effectiveness of Cre8 stent, Cre8 evo stent in patients with ischemic heart disease with long coronary lesions Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Drug Eluting Stent
- What is being tested?
- CRE8 polymer-free Amphilimus-eluting stent, Cre8 evo stent
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Aug 2021to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 300 patients underwent Cre 8 stent, Cre8 evo stent implantation of 30 mm or more
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of CRE8 Polymer-free Amphilimus-eluting sTEnt in Patients With Diffuse Long Lesions (CREATE Trial): Prospective, Observational Study
Observation of the safety and effectiveness of Cre8 stent, Cre8 evo stent in patients with ischemic heart disease with long coronary lesions
Read the 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.
- Conditions
- Coronary Artery Disease, Drug Eluting Stent
- Being tested
- CRE8 polymer-free Amphilimus-eluting stent, Cre8 evo stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRE8 polymer-free Amphilimus-eluting stent, Cre8 evo stentDevice
Percutaneous coronary intervention using a Cre8 stent, Cre8 evo stent for long lesions
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure including deaht, MI, ST, TLR
number of Target lesion failure including deaht, MI, ST, TLR
Measured: 12 months after the index procedure
Secondary outcomes (9)
All cause death
number of All cause death
Measured: 12 months after the index procedure
Cardiac death
number of Cardiac death
Measured: 12 months after the index procedure
Myocardial infarction
number of Myocardial infarction
Measured: 12 months after the index procedure
Stent thrombosis : definite or probable stent thrombosis by ARC definition
number of Stent thrombosis
Measured: 12 months after the index procedure
Target lesion revascularization
number of Target lesion revascularization
Measured: 12 months after the index procedure
Target vessel revascularization
number of Target vessel revascularization
Measured: 12 months after the index procedure
Stroke
number of Stroke
Measured: 12 months after the index procedure
BARC bleeding 2-5
number of BARC bleeding 2-5
Measured: 12 months after the index procedure
Stent overexpansion by OCT
Maximal stent diameter/ each diameter of stent
Measured: immediately after the index procedure in hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start3 Aug 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Dio
- Responsible party
- Principal investigator, Deok-Kyu Cho, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658250
- Sponsor's protocol ID
- 9-2021-0093
- Status last verified
- Nov 2025
- First submitted
- 12 Dec 2022
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of CRE8 Polymer-free Amphilimus-eluting sTEnt in Patients With Diffuse Long Lesions (CREATE Trial): Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT05658250
- Acronym / sponsor ID
- 9-2021-0093
- Conditions
- Coronary Artery Disease, Drug Eluting Stent
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Dio
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 300 patients underwent Cre 8 stent, Cre8 evo stent implantation of 30 mm or more
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRE8 polymer-free Amphilimus-eluting stent, Cre8 evo stentPercutaneous coronary intervention using a Cre8 stent, Cre8 evo stent for long lesions | Device | – |
Primary outcome
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
9 secondary outcomes
All cause death
Time frame: 12 months after the index procedure
Cardiac death
Time frame: 12 months after the index procedure
Myocardial infarction
Time frame: 12 months after the index procedure
Stent thrombosis : definite or probable stent thrombosis by ARC definition
Time frame: 12 months after the index procedure
Target lesion revascularization
Time frame: 12 months after the index procedure
Target vessel revascularization
Time frame: 12 months after the index procedure
Stroke
Time frame: 12 months after the index procedure
BARC bleeding 2-5
Time frame: 12 months after the index procedure
Stent overexpansion by OCT
Time frame: immediately after the index procedure in hospitalization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Drug Eluting Stent, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure including deaht, MI, ST, TLR (time frame: 12 months after the index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.