CREATE Trial, Prospective, Observational Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Drug Eluting Stent
• Intervention / Treatment: Device: CRE8 polymer-free Amphilimus-eluting stent, Cre8 evo stent

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do
    • Yongin, Gyeonggi-do, South Korea, 16995
      • Yongin Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

300 patients underwent Cre 8 stent, Cre8 evo stent implantation of 30 mm or more

Description

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.)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause death	number of All cause death	12 months after the index procedure
Cardiac death	number of Cardiac death	12 months after the index procedure
Myocardial infarction	number of Myocardial infarction	12 months after the index procedure
Stent thrombosis : definite or probable stent thrombosis by ARC definition	number of Stent thrombosis	12 months after the index procedure
Target lesion revascularization	number of Target lesion revascularization	12 months after the index procedure
Target vessel revascularization	number of Target vessel revascularization	12 months after the index procedure
Stroke	number of Stroke	12 months after the index procedure
BARC bleeding 2-5	number of BARC bleeding 2-5	12 months after the index procedure
Stent overexpansion by OCT	Maximal stent diameter/ each diameter of stent	immediately after the index procedure in hospitalization

Collaborators and Investigators

• Sponsor: Yonsei University
• Collaborators: Dio

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 9-2021-0093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No