Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04765592
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2021-02-04
Brief Title:
Guos Aortic Arch Reconstruction The Prospective Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System GIANT Study
Sponsor:
Hangzhou Endonom Medtech Co Ltd
Organization:
Hangzhou Endonom Medtech Co Ltd
Study Overview
Official Title:
Guos Aortic Arch Reconstruction The Prospective Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System GIANT Study
Status:
ACTIVE_NOT_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:
A prospective Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System manufactured by EndoNom Medtech Hangzhou Co Ltd for truefalse aortic arch aneurysms and ulcers involving aortic arch GIANT Study
Detailed Description:
This study is a prospective multiple center study about the safety and efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System it is expected to complete the implantation of 80 patients in 23 centers within 12 months and interim follow-up was conducted before discharge 30 days after surgery 6 months after surgery and 12 months after surgery long-term follow-up will be performed at 24 months postoperatively 36 months postoperatively 48 months postoperatively and 60 months postoperatively
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