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Feasibility of CRE8 polymer-free Amphilimus-eluting sTEnt in patients with diffuse long lesions (CREATE trial ): Prospective, Observational study

Feasibility of CRE8 polymer-free Amphilimus-eluting sTEnt in patients with diffuse long lesions (CREATE trial ): Prospective, Observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0007362
Enrollment
300
Registered
2022-06-08
Start date
2021-08-03
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Yonsei University Yongin Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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 (an unstable angina, non-ST segmental ascending myocardial infarction, ST segmental ascending myocardial infarction) 3. Coronary lesion length greater than 30 mm 4. Voluntary written consent to participate in this clinical study

Exclusion criteria

Exclusion criteria: 1. Life expectancy within one year 2. Subjects with known intolerance or contraindications for the following drugs or substances: heparin, aspirin, clopidogrel, prashgrel, ticagreler 3. If other researchers decide that they are unsuitable for participation in this study (pregnant women, the elderly, etc.)

Design outcomes

Primary

MeasureTime frame
The incidence of one-year target lesion failure (a combination of cardiac death, target vascular myocardial infarction, and ischemic-induced target lesion re-perfusion)

Secondary

MeasureTime frame
One-year major cardiac adverse events (complex variables of death, myocardial infarction, stent thrombosis, and targeted lesion perfusion);a one-year incidence of heart death;1-year incidence of non-heart death;1-year target cardiomyopathy incidence;1-year incidence of non-targeted cardiomyopathy;Acute stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and incidence of late stent thrombosis in year 1;1 Year Ischemia-Induced Target Lesions Recurrent;1-year ischemic target lesion re-perfusion;a one-year stroke;Major bleeding rates per year (Bleeding Academic Research Consortium 3-5);For those who have performed 46mm Cre8 stent, whether or not overexpansion through OCT is achieved through OCT;In patients with acute myocardial infarction, the primary/secondary effectiveness of antiplatelet drugs is re-evaluated (clopidogrel vs prasugrel vs ticagrel on acute myocardial infraction)

Countries

Korea, Republic of

Contacts

Public ContactDeokKyu Cho

Yonsei University Yongin Severance Hospital

chodk123@yuhs.ac+82-31-5189-8755

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026