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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
ViTAA Medical Solutions
Study ID
NCT05004051
Status
Recruiting

Conditions

  • Abdominal Aortic Aneurysms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ViTAA Analysis — DEVICE
    Imaging Analysis Software

Study Details

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.

Key Dates

Start date
Dec 15, 2021
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Patients who are booked for and then subsequently have undergone endovascular repair.
    Patients who are scheduled and ultimately receive on-IFU endovascular infrarenal aortic aneurysm repair (EVAR)
  • Arm: Patients with infrarenal AA without indications for repair undergoing serial monitoring
    Patients who do not yet qualify for the aortic aneurysm repair who are enrolled in a serial monitoring program

Primary Outcome Measure

Composite of aneurysm rupture or critical growth. [ Time Frame: 6 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
UAB - University of Alabama in Birmingham HospitalBirminghamAlabama35233
Rebecca St John
Adam Beck, MD (PRINCIPAL_INVESTIGATOR)
MGH - Massachusetts General Hospital Fireman Vascular CenterBostonMassachusetts02114
Jamie Attwood, RN
Matt Eagleton, MD (PRINCIPAL_INVESTIGATOR)
UNC - University of North Carolina at Chapel HillChapel HillNorth Carolina27514
Rebekah Roten
Mark Farber, MD (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98104
Allison Larimore, MSN, RN, CCRN
206-744-8257
Sonja Katt
206-744-8257
Benjamin Starnes, MD (PRINCIPAL_INVESTIGATOR)

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