Abdominal Aortic AneurysmsNCT05004051
ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial Monitoring for AAA
An observational study of Abdominal Aortic Aneurysms, run by ViTAA Medical Solutions at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms
- What is being tested?
- ViTAA Analysis
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 15 Dec 2021to 31 Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patients who are booked for and then subsequently have undergone endovascular repair. 2. Patients with infrarenal aortic aneurysms without indications for repair undergoing serial monitoring.
Who may be able to join
- Patient is aged 18 years or over
- Infrarenal Aortic Aneurysm ≥ 45 mm in diameter.
- Patient meets on-IFU criteria for endovascular reconstruction
Who cannot join
- Patient has a known or clinically suspected major connective tissue disorder, autoimmune disorder, vasculitis, or aortic dissection.
- Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.0mg/dL or 175umol/L
- Patients with previous aortic reconstruction in the involved segment.
- Patients receiving oral or parenteral corticosteroid therapy for other unrelated disease. (Excludes inhaled corticosteroids).
- Patient has a sensitivity to contrast imaging agents.
- Patient has aortic dissection.
- Patient has atrial fibrillation.
- Patient has arrhythmia.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
UAB - University of Alabama in Birmingham Hospital
Birmingham, Alabama, 35233
Rebecca St John, rstjohn@uabmc.edu
Adam Beck, MD
- Recruiting
MGH - Massachusetts General Hospital Fireman Vascular Center
Boston, Massachusetts, 02114
Jamie Attwood, RN, jlattwood@mgh.harvard.edu
Matt Eagleton, MD
- Recruiting
UNC - University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Rebekah Roten, rebekah_roten@med.unc.edu
Mark Farber, MD
- Recruiting
University of Washington
Seattle, Washington, 98104
Allison Larimore, MSN, RN, CCRN, 206-744-8257, alari@uw.edu
Sonja Katt, 206-744-8257, skatt@uw.edu
Canada4 sites, 4 recruiting
- Recruiting
UCGY - University of Calgary, Peter Lougheed Center
Calgary, Alberta, T1Y 6J4
Emi Sanders, emi.sanders@albertahealthservices.ca
Paul Petrasek, MD
- Recruiting
CHUM - Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
Jennifer Satterthwaite, 514 890-8000 ext. 23483, jennifer.satterthwaite.chum@ssss.gouv.qc.ca
Casey Bourdeau-Caporuscio, BSc, MSc, 514-890-8000 ext. 14756, casey.bourdeau-caporuscio.chum@ssss.gouv.qc.ca
- Recruiting
MUHC - McGill University Health Centre
Montreal, Quebec, H4A 3J1
Marie-Amélie Lukaszewski, +1 514-934-1934 ext. 35113, marie-amelie.lukaszewski@muhc.mcgill.ca
Kent MacKenzie, MD
- Recruiting
UHN - University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4
Naomi Eisenberg, Naomi.Eisenberg@uhn.ca
Thomas Forbes, MD
About this study
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
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.
Read the 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
- Being tested
- ViTAA Analysis
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViTAA AnalysisDevice
Imaging Analysis Software
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: ViTAA Analysis | |
| 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 Receives: Device: ViTAA Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of aneurysm rupture or critical growth.
- Critical growth defined as an increase of > 0.5 cm in any of the three growth measurements below
- Critical growth defined as an increase of > 0.5 cm in aortic diameter.
- Critical growth defined as an increase of > 0.5 cm in ILT.
- Critical growth defined as an increase of > 0.5 cm in aneurysm sac volume.
Measured: 6 months
Composite of aneurysm rupture or critical growth.
- Critical growth defined as an increase of > 0.5 cm in any of the three growth measurements below
- Critical growth defined as an increase of > 0.5 cm in aortic diameter.
- Critical growth defined as an increase of > 0.5 cm in ILT.
- Critical growth defined as an increase of > 0.5 cm in aneurysm sac volume.
Measured: 1 year
Secondary outcomes (2)
CHUM Ancillary Ultrasound Study
For patients recruited at the CHUM:
- Correlation between ultrasound and multiphase CT based strain and RAW values
- Correlation between AAA growth and ultrasound-based strain and RAW maps
Measured: 6 months
CHUM Ancillary Ultrasound Study
For patients recruited at the CHUM:
- Correlation between ultrasound and multiphase CT based strain and RAW values
- Correlation between AAA growth and ultrasound-based strain and RAW maps
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start15 Dec 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- ViTAA Medical Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr Mark Farber, ViTAA Medical Solutions
- Investigators
- Mark Farber, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004051
- Sponsor's protocol ID
- CIP-ViTAA-001
- Status last verified
- Sep 2025
- First submitted
- 29 Jul 2021
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05004051
- Acronym / sponsor ID
- CIP-ViTAA-001
- Conditions
- Abdominal Aortic Aneurysms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- ViTAA Medical SolutionsIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who are booked for and then subsequently have undergone endovascular repair. | – | Device: ViTAA AnalysisPatients who are scheduled and ultimately receive on-IFU endovascular infrarenal aortic aneurysm repair (EVAR) |
| Patients with infrarenal AA without indications for repair undergoing serial monitoring | – | Device: ViTAA AnalysisPatients who do not yet qualify for the aortic aneurysm repair who are enrolled in a serial monitoring program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients who are booked for and then subsequently have undergone endovascular repair. 2. Patients with infrarenal aortic aneurysms without indications for repair undergoing serial monitoring.
Key inclusion criteria (3 listed)
- Patient is aged 18 years or over
- Infrarenal Aortic Aneurysm ≥ 45 mm in diameter.
- Patient meets on-IFU criteria for endovascular reconstruction
Key exclusion criteria (8 listed)
- Patient has a known or clinically suspected major connective tissue disorder, autoimmune disorder, vasculitis, or aortic dissection.
- Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.0mg/dL or 175umol/L
- Patients with previous aortic reconstruction in the involved segment.
- Patients receiving oral or parenteral corticosteroid therapy for other unrelated disease. (Excludes inhaled corticosteroids).
- Patient has a sensitivity to contrast imaging agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ViTAA AnalysisImaging Analysis Software | Device | Patients who are booked for and then subsequently have undergone endovascular repair., Patients with infrarenal AA without indications for repair undergoing serial monitoring |
Primary outcome
Composite of aneurysm rupture or critical growth.
Time frame: 6 months
* Critical growth defined as an increase of > 0.5 cm in any of the three growth measurements below * Critical growth defined as an increase of > 0.5 cm in aortic diameter. * Critical growth defined as an increase of > 0.5 cm in ILT. * Critical growth defined as an increase of > 0.5 cm in aneurysm sac volume.
Composite of aneurysm rupture or critical growth.
Time frame: 1 year
* Critical growth defined as an increase of > 0.5 cm in any of the three growth measurements below * Critical growth defined as an increase of > 0.5 cm in aortic diameter. * Critical growth defined as an increase of > 0.5 cm in ILT. * Critical growth defined as an increase of > 0.5 cm in aneurysm sac volume.
2 secondary outcomes
CHUM Ancillary Ultrasound Study
Time frame: 6 months
CHUM Ancillary Ultrasound Study
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Farber principal investigator
University of North Carolina, Chapel Hill
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysms, run by ViTAA Medical Solutions at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denis Bilodeau (5145728673, denisbilodeau@vitaamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of aneurysm rupture or critical growth. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.