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NCT Number: NCT05658250

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Drug Eluting Stent Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yongin Severance Hospital

Yongin, Gyeonggi-do, 16995, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.)

Treatment and study plan

CRE8 polymer-free Amphilimus-eluting stent, Cre8 evo stent

Device

Percutaneous coronary intervention using a Cre8 stent, Cre8 evo stent for long lesions

Primary outcomes

  1. 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

Secondary outcomes

  1. All cause death

    Time frame: 12 months after the index procedure

    number of All cause death

  2. Cardiac death

    Time frame: 12 months after the index procedure

    number of Cardiac death

  3. Myocardial infarction

    Time frame: 12 months after the index procedure

    number of Myocardial infarction

  4. Stent thrombosis : definite or probable stent thrombosis by ARC definition

    Time frame: 12 months after the index procedure

    number of Stent thrombosis

  5. Target lesion revascularization

    Time frame: 12 months after the index procedure

    number of Target lesion revascularization

  6. Target vessel revascularization

    Time frame: 12 months after the index procedure

    number of Target vessel revascularization

  7. Stroke

    Time frame: 12 months after the index procedure

    number of Stroke

  8. BARC bleeding 2-5

    Time frame: 12 months after the index procedure

    number of BARC bleeding 2-5

  9. Stent overexpansion by OCT

    Time frame: immediately after the index procedure in hospitalization

    Maximal stent diameter/ each diameter of stent

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Dio

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Dec 20, 2022
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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