Ignite Creation Date:
2024-05-06 @ 4:30 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05004051
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2021-07-29
Brief Title:
ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial Monitoring for AAA
Sponsor:
ViTAA Medical Solutions
Organization:
ViTAA Medical Solutions
Study Overview
Official Title:
Prospective Registry Study to Collect Imaging and Clinical Data on Patients With Aortic Aneurysm Disease Undergoing Serial Monitoring Pre and Post Endovascular Repair
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:
This is a Prospective Registry study to collect imaging and clinical data both on patients with aortic aneurysm disease undergoing serial monitoring and on patients pre and post-endovascular repair using ViTAA The Sponsor aortic mapping technology
Detailed Description:
This a prospective multi-center registry of patients that are being assessed with the ViTAA software Patients will be enrolled at selected North American centers in the US and Canada The Registry will enroll patients from the following two populations
patients who are scheduled and ultimately receive endovascular infrarenal aortic aneurysm repair EVAR
patients who do not yet qualify for infrarenal aortic aneurysm repair based on anatomic size criteria who are enrolled in a serial monitoring program
patients who are scheduled and ultimately receive endovascular infrarenal aortic aneurysm repair EVAR
patients who do not yet qualify for infrarenal aortic aneurysm repair based on anatomic size criteria who are enrolled in a serial monitoring program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None