NCT05658250

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
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Coronary Artery Disease
• Drug Eluting Stent

Interventions

Type	Name	Description
DEVICE	CRE8 polymer-free Amphilimus-eluting stent, Cre8 evo stent	Percutaneous coronary intervention using a Cre8 stent, Cre8 evo stent for long lesions

Timeline

• Start date: 2021-08-03
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2022-12-20
• Last updated: 2025-11-25

Locations

1 site across 1 country: South Korea