Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05864560
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2023-05-09
Brief Title:
Ankura AAA Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up
Sponsor:
Lifetech Scientific Shenzhen Co Ltd
Organization:
Lifetech Scientific Shenzhen Co Ltd
Study Overview
Official Title:
Ankura AAA Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up A Multi-center Prospective Single-arm Open-label Post-market 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:
The objective of the study is to collect real-world data on patient outcomes and evaluate the safety and performance of the Lifetech Ankura AAA Stent Graft System Ankura Cuff Stent Graft System Ankura AUI Stent Graft System and ZoeTrack Super Stiff Guidewire
Detailed Description:
Abdominal aortic aneurysm AAA is the most common true arterial aneurysm Surgical management options for AAA include traditional Open Surgical Repair OSR and minimally invasive Endovascular Aneurysm Repair EVAR Multiple endovascular devices are commercially available for repair of AAA Currently available endovascular grafts for infrarenal aortic repair share a bifurcated modular design Ankura Stent Graft Systems are minimally invasive endovascular devices that offer an alternative treatment for patients with AAA which have been marketed worldwide for many years In order to evaluate the long-term safety and performance of the investigational device from real world this post-market clinical follow-up study is planned under the Regulation EU 2017745 The study intends to enroll 162 subjects The anticipated enrollment period is approximately 15 years and subjects will be followed for 3 years 36 months post-implantation
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