Trials / Recruiting
RecruitingNCT05759676
Efficacy and Safety of Polymer-free Amphilimus-eluting Stent According to the Diabetes
A Prospective, Multicenter Observational Study of Efficacy and Safety of Polymer-free Amphilimus-eluting Stent (Cre8™/Cre8™ EVO) in Patients With Coronary Artery Disease According to the Presence of Diabetes Mellitus
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,800 (estimated)
- Sponsor
- Korea University Anam Hospital · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Cre8™/Cre8™ EVO drug-eluting stent | Patient with CAD who undergoing PCI with Cre8™/Cre8™ EVO drug-eluting stent |
Timeline
- Start date
- 2023-03-09
- Primary completion
- 2026-08-31
- Completion
- 2026-12-31
- First posted
- 2023-03-08
- Last updated
- 2024-04-04
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05759676. Inclusion in this directory is not an endorsement.