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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ViTAA Analysis | Device | Imaging Analysis Software |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of aneurysm rupture or critical growth. |
| 6 months |
| Composite of aneurysm rupture or critical growth. |
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| CHUM Ancillary Ultrasound Study | For patients recruited at the CHUM:
| 6 months |
| CHUM Ancillary Ultrasound Study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Denis Bilodeau | Contact | 5145728673 | denisbilodeau@vitaamedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Mark Farber | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB - University of Alabama in Birmingham Hospital | Recruiting | Birmingham | Alabama | 35233 | United States |
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For patients recruited at the CHUM:
|
| 1 year |
| MGH - Massachusetts General Hospital Fireman Vascular Center | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| UNC - University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
|
| University of Washington | Recruiting | Seattle | Washington | 98104 | United States |
|
| UCGY - University of Calgary, Peter Lougheed Center | Recruiting | Calgary | Alberta | T1Y 6J4 | Canada |
|
| UHN - University Health Network - Toronto General Hospital | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
|
| CHUM - Centre Hospitalier de l'Université de Montréal | Recruiting | Montreal | Quebec | H2X 3E4 | Canada |
|
| MUHC - McGill University Health Centre | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
|
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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