Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06075368
Status:
RECRUITING
Last Update Posted:
2023-10-17
First Post:
2023-10-04
Brief Title:
Prospective Registry of Patients With Acute Coronary Syndrome Treated With GENOSS Stent
Sponsor:
Genoss Co Ltd
Organization:
Genoss Co Ltd
Study Overview
Official Title:
A Multi-center Prospective Registry of Patients With Acute Coronary Syndrome ACS Treated With GENOSSTM Sirolimus-eluting Stent
Status:
RECRUITING
Status Verified Date:
2023-10
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:
GENOSSACS
Brief Summary:
The investigators intend to establish a multi-center prospective observational study to evaluate the effectiveness and safety of Genoss DES by registering and tracking patients treated for acute coronary syndrome ACS as research subjects using Genoss DES which was manufactured purely with domestic technology
Detailed Description:
This study is a sponsor-initiated clinical trial SIT that will enroll patients treated for acute coronary syndrome using the GENOSS stent as research subjects collect data on the patients clinical and surgical procedures and track the occurrence of clinical events
This study is a prospective multicenter registration observational study enrolling patients with acute coronary artery disease treated using the GENOSS stent at a total of 10 institutions
Since this study is a registered observation study the number of subjects is not calculated separately but a total of 1000 subjects are scheduled to be recruited during the study registration period
This study is a prospective multicenter registration observational study enrolling patients with acute coronary artery disease treated using the GENOSS stent at a total of 10 institutions
Since this study is a registered observation study the number of subjects is not calculated separately but a total of 1000 subjects are scheduled to be recruited 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