Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06001918
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-08-07
Brief Title:
Nectero EAST System Clinical Study
Sponsor:
Nectero Medical Inc
Organization:
Nectero Medical Inc
Study Overview
Official Title:
Randomized Controlled Clinical Trial RCT of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms AAA StaBiLization Evaluation of Efficacy
Status:
RECRUITING
Status Verified Date:
2024-10
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:
stAAAble
Brief Summary:
The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms AAA maximum diameter of 35 cm to 50 cm using a locally delivered single-dose endovascular treatment The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAAThe study will compare the treatment group to the typical standard of care for these patients surveillance All subjects will be followed at designated intervals at 3060 days 6 12 18 and 24 months with continued follow-up annually for up to 5 years
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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