Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06168305
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-11-28
Brief Title:
Safety and Effectiveness of GENOSS DES in Patients With Multivessel Coronary Artery Disease
Sponsor:
Genoss Co Ltd
Organization:
Genoss Co Ltd
Study Overview
Official Title:
Safety and Effectiveness of GENOSS DES Sirolimus-eluting Coronary Stent System in Patients With Multivessel Coronary Artery Disease MVCAD A Multicenter Prospective Observational Study GENOSS-MV
Status:
RECRUITING
Status Verified Date:
2023-12
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:
GENOSS-MV
Brief Summary:
The investigators intend to establish a multicenter prospective observational study by enrolling and tracking patients with multivessel coronary artery disease MVCAD using Genoss DES a device manufactured with pure domestic technology The study aims to evaluate the efficacy and safety of Genoss DES in MVCAD patients
Detailed Description:
This study is a sponsor-driven clinical trial SIT that aims to enroll patients who have undergone treatment for multivessel coronary artery disease using Genoss stents The study involves collecting data on the clinical and surgical processes of patients and tracking the occurrence of clinical events
This prospective multicenter observational study registers patients with acute coronary artery disease who have been treated with GENOSS stents at a total of 8 institutions
As it is an observational study the number of subjects is not separately calculated but the plan is to recruit a total of 1000 participants during the study registration period
This prospective multicenter observational study registers patients with acute coronary artery disease who have been treated with GENOSS stents at a total of 8 institutions
As it is an observational study the number of subjects is not separately calculated but the plan is to recruit a total of 1000 participants during the study registration period
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