Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385379
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-22
Brief Title:
Guos Aortic Arch Reconstruction A Multicenter Prospective Study of the Novel WeFlow-Tribranch System GENIUS Study
Sponsor:
Hangzhou Endonom Medtech Co Ltd
Organization:
Hangzhou Endonom Medtech Co Ltd
Study Overview
Official Title:
Guos Aortic Arch Reconstruction A Multicenter Prospective Study of the Novel WeFlow-Tribranch Unique Embedded Aortic Triple-branch Arch Stent Graft System GENIUS Study
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:
A prospective Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech Hangzhou Co Ltd for truepseudo aortic arch aneurysms and ulcers involving aortic arch GENIUS Study
Detailed Description:
This study is a prospective multiple center study about the safety and efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System it is expected to complete the implantation of 90 patients in 20 centers within 20 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 24th month 36th month 48th month and 60th month 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