Ignite Creation Date:
2024-05-06 @ 2:07 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04220177
Status:
UNKNOWN
Last Update Posted:
2020-01-09
First Post:
2020-01-05
Brief Title:
Safety and Efficacy of the SETA LATECBA Stent Graft for EVAR in Subjects With AAA
Sponsor:
Latecba SA
Organization:
Latecba SA
Study Overview
Official Title:
Prospective Open-label Multicenter Non-randomized Clinical Study to Determine the Safety and Efficacy of SETA LATECBA Stent Graft for Endovascular Repair Therapy EVAR in Subjects With Abdominal Aortic Aneurysm AAA
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
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:
This is a Prospective Open-label Multicenter and Non-randomized Clinical Study The main purpose of this study is to establish the efficacy and safety of a medical device system SETA LATECBA Stent Graft intended for the treatment of EVAR of pararenal AAA patients with complex anatomy not eligible for other surgical procedureOther objective is to evaluate the technical performance of the device SETA LATECBA Stent Graft
Detailed Description:
This is a Prospective Open-label Multicenter and Non-randomized Clinical Study to determine the Safety and Efficacy of the SETA LATECBA Stent Graft for endovascular repair therapy EVAR in Subjects with Abdominal Aortic Aneurysm AAAThe main purpose of this study is to establish the efficacy and safety of a medical device system SETA LATECBA Stent Graft intended for the treatment of Endovascular Aneurysm Repair EVAR of pararenal AAA patients with complex anatomy not eligible for other surgical procedure
Secondary objectives The secondary objective is to evaluate the technical performance of the device SETA LATECBA Stent Graft which includes access to the implantation site visualization deployment of the stent- graft sizing compatibility withdrawal of the delivery system and compatibility with ancillary equipment
Secondary objectives The secondary objective is to evaluate the technical performance of the device SETA LATECBA Stent Graft which includes access to the implantation site visualization deployment of the stent- graft sizing compatibility withdrawal of the delivery system and compatibility with ancillary equipment
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?:
False
Is an FDA AA801 Violation?:
None