NCT05004051

ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial Monitoring for AAA

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
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: ViTAA Medical Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Aortic Aneurysms

Interventions

Type	Name	Description
DEVICE	ViTAA Analysis	Imaging Analysis Software

Timeline

• Start date: 2021-12-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-08-13
• Last updated: 2025-09-19

Locations

8 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study