Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05759676
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2023-02-26
Brief Title:
Efficacy and Safety of Polymer-free Amphilimus-eluting Stent According to the Diabetes
Sponsor:
Korea University Anam Hospital
Organization:
Korea University Anam Hospital
Study Overview
Official Title:
A Prospective Multicenter Observational Study of Efficacy and Safety of Polymer-free Amphilimus-eluting Stent Cre8Cre8 EVO in Patients With Coronary Artery Disease According to the Presence of Diabetes Mellitus
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None