Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-26 @ 2:57 PM
Study NCT ID:
NCT05133492
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2021-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First In Human Study for Small to Medium-sized Abdominal Aortic Aneurysm (AAA)
Sponsor:
Nectero Medical, Inc.
Organization:
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:
2025-12
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:
False
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?: