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Efficacy and Safety of Polymer-free Amphilimus-eluting Stent According to the Diabetes

NCT05759676 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1800

Last updated 2024-04-04

No results posted yet for this study

Summary

Drug-eluting stents (DES) have been found to reduce the rate of stent restenosis compared to bare metal stents (BMS), but the first generation DES caused an increase in stent thrombosis. The second generation DES, including the Cre8Evo stent, has been designed to address these issues. The Cre8Evo stent is made of cobalt chromium and releases the drug amphilimus into the vessel wall, which is quickly absorbed and then lost, creating a BMS-like form. The Cre8Evo stent does not contain polymers and does not induce an inflammatory response. It inhibits cdk2 and RhoA, reducing the proliferation and migration of vascular smooth muscle cells. In diabetic patients, the Cre8Evo stent showed superior results in suppressing late proliferation compared to conventional DES. The Cre8Evo stent has been found to be safe and effective in clinical studies, and it has a superior effect in the clinical course of diabetic patients compared to other stents. The purpose of the study is to evaluate the effectiveness and safety of the Cre8Evo stent in actual clinical practice, specifically comparing outcomes in patients with and without diabetes.

Conditions

Interventions

DEVICE

Cre8™/Cre8™ EVO drug-eluting stent

Patient with CAD who undergoing PCI with Cre8™/Cre8™ EVO drug-eluting stent

Sponsors & Collaborators

  • Diomedical

    collaborator UNKNOWN

  • Korea University Anam Hospital

    lead OTHER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-09
Primary Completion
2026-08-31
Completion
2026-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05759676 on ClinicalTrials.gov