Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05133492
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2021-11-03
Brief Title:
First In Human Study for Small to Medium-sized Abdominal Aortic Aneurysm AAA
Sponsor:
Nectero Medical Inc
Organization:
Nectero Medical Inc
Study Overview
Official Title:
A Clinical Pilot Study to Evaluate the Safety and Clinical Utility of The Nectero EAST System for Stabilization of Abdominal Aortic Aneurysms
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
AAA
Brief Summary:
This is a first in human study to evaluate the safety and clinical utility of an investigational medical device called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA
Detailed Description:
This is a Phase I multi-center open-label study to evaluate use of the Nectero EAST system for stabilization of abdominal aortic aneurysms Up to fifty 50 subjects will be treated at up to 10 worldwide sites with the device and followed for up to 36-months
Primary Study Endpoints
Safety absence of major events within the 1-month follow-up visit
Success defined as successful insertion of the delivery catheter and delivery of the Stabilizer
Secondary Study Endpoints
Freedom from aneurysmal sac enlargement Enlargement is defined as diameter increase of 5mm per year or aneurysm sac volume increase of 10 per year as assessed by CT scans at the 1 3 HK only 6 12 24 and 36-month follow-up visits
Aneurysm sac shrinkage defined as diameter decrease of 5mm or decrease in aneurysm sac volume of 10 as assessed by CT scans at the 1 3 HK only 6 12 24 and 36-month follow-up visits
Assessment of Clinical Utility
Study duration is anticipated to be 6 years
Primary Study Endpoints
Safety absence of major events within the 1-month follow-up visit
Success defined as successful insertion of the delivery catheter and delivery of the Stabilizer
Secondary Study Endpoints
Freedom from aneurysmal sac enlargement Enlargement is defined as diameter increase of 5mm per year or aneurysm sac volume increase of 10 per year as assessed by CT scans at the 1 3 HK only 6 12 24 and 36-month follow-up visits
Aneurysm sac shrinkage defined as diameter decrease of 5mm or decrease in aneurysm sac volume of 10 as assessed by CT scans at the 1 3 HK only 6 12 24 and 36-month follow-up visits
Assessment of Clinical Utility
Study duration is anticipated to be 6 years
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