Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 12:00 PM
Study NCT ID:
NCT05004051
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2021-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial Monitoring for AAA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2021-07-29', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of aneurysm rupture or critical growth.', 'timeFrame': '6 months', 'description': '* Critical growth defined as an increase of \\> 0.5 cm in any of the three growth measurements below\n* Critical growth defined as an increase of \\> 0.5 cm in aortic diameter.\n* Critical growth defined as an increase of \\> 0.5 cm in ILT.\n* Critical growth defined as an increase of \\> 0.5 cm in aneurysm sac volume.'}, {'measure': 'Composite of aneurysm rupture or critical growth.', 'timeFrame': '1 year', 'description': '* Critical growth defined as an increase of \\> 0.5 cm in any of the three growth measurements below\n* Critical growth defined as an increase of \\> 0.5 cm in aortic diameter.\n* Critical growth defined as an increase of \\> 0.5 cm in ILT.\n* Critical growth defined as an increase of \\> 0.5 cm in aneurysm sac volume.'}], 'secondaryOutcomes': [{'measure': 'CHUM Ancillary Ultrasound Study', 'timeFrame': '6 months', 'description': 'For patients recruited at the CHUM:\n\n1. Correlation between ultrasound and multiphase CT based strain and RAW values\n2. Correlation between AAA growth and ultrasound-based strain and RAW maps'}, {'measure': 'CHUM Ancillary Ultrasound Study', 'timeFrame': '1 year', 'description': 'For patients recruited at the CHUM:\n\n1. Correlation between ultrasound and multiphase CT based strain and RAW values\n2. Correlation between AAA growth and ultrasound-based strain and RAW maps'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Abdominal Aortic Aneurysms']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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:\n\n* patients who are scheduled and ultimately receive endovascular infrarenal aortic aneurysm repair (EVAR);\n* patients who do not yet qualify for infrarenal aortic aneurysm repair based on anatomic size criteria who are enrolled in a serial monitoring program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Patients who are booked for and then subsequently have undergone endovascular repair.\n2. Patients with infrarenal aortic aneurysms without indications for repair undergoing serial monitoring.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is aged 18 years or over\n2. Infrarenal Aortic Aneurysm ≥ 45 mm in diameter.\n3. Patient meets on-IFU criteria for endovascular reconstruction\n\nExclusion Criteria:\n\n1. Patient has a known or clinically suspected major connective tissue disorder, autoimmune disorder, vasculitis, or aortic dissection.\n2. Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.0mg/dL or 175umol/L\n3. Patients with previous aortic reconstruction in the involved segment.\n4. Patients receiving oral or parenteral corticosteroid therapy for other unrelated disease. (Excludes inhaled corticosteroids).\n5. Patient has a sensitivity to contrast imaging agents.\n6. Patient has aortic dissection.\n7. Patient has atrial fibrillation.\n8. Patient has arrhythmia.'}, 'identificationModule': {'nctId': 'NCT05004051', 'briefTitle': 'ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial Monitoring for AAA', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViTAA Medical Solutions'}, 'officialTitle': 'Prospective Registry Study to Collect Imaging and Clinical Data on Patients With Aortic Aneurysm Disease Undergoing Serial Monitoring & Pre and Post Endovascular Repair', 'orgStudyIdInfo': {'id': 'CIP-ViTAA-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who are booked for and then subsequently have undergone endovascular repair.', 'description': 'Patients who are scheduled and ultimately receive on-IFU endovascular infrarenal aortic aneurysm repair (EVAR)', 'interventionNames': ['Device: ViTAA Analysis']}, {'label': 'Patients with infrarenal AA without indications for repair undergoing serial monitoring', 'description': 'Patients who do not yet qualify for the aortic aneurysm repair who are enrolled in a serial monitoring program', 'interventionNames': ['Device: ViTAA Analysis']}], 'interventions': [{'name': 'ViTAA Analysis', 'type': 'DEVICE', 'description': 'Imaging Analysis Software', 'armGroupLabels': ['Patients who are booked for and then subsequently have undergone endovascular repair.', 'Patients with infrarenal AA without indications for repair undergoing serial monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca St John', 'role': 'CONTACT', 'email': 'rstjohn@uabmc.edu'}, {'name': 'Adam Beck, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UAB - University of Alabama in Birmingham Hospital', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jamie Attwood, RN', 'role': 'CONTACT', 'email': 'jlattwood@mgh.harvard.edu'}, {'name': 'Matt Eagleton, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MGH - Massachusetts General Hospital Fireman Vascular Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebekah Roten', 'role': 'CONTACT', 'email': 'rebekah_roten@med.unc.edu'}, {'name': 'Mark Farber, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UNC - University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Allison Larimore, MSN, RN, CCRN', 'role': 'CONTACT', 'email': 'alari@uw.edu', 'phone': '206-744-8257'}, {'name': 'Sonja Katt', 'role': 'CONTACT', 'email': 'skatt@uw.edu', 'phone': '206-744-8257'}, {'name': 'Benjamin Starnes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'T1Y 6J4', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Emi Sanders', 'role': 'CONTACT', 'email': 'emi.sanders@albertahealthservices.ca'}, {'name': 'Paul Petrasek, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCGY - University of Calgary, Peter Lougheed Center', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Naomi Eisenberg', 'role': 'CONTACT', 'email': 'Naomi.Eisenberg@uhn.ca'}, {'name': 'Thomas Forbes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UHN - University Health Network - Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 3E4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jennifer Satterthwaite', 'role': 'CONTACT', 'email': 'jennifer.satterthwaite.chum@ssss.gouv.qc.ca', 'phone': '514 890-8000', 'phoneExt': '23483'}, {'name': 'Casey Bourdeau-Caporuscio, BSc, MSc', 'role': 'CONTACT', 'email': 'casey.bourdeau-caporuscio.chum@ssss.gouv.qc.ca', 'phone': '514-890-8000', 'phoneExt': '14756'}, {'name': 'Gilles Soulez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CHUM - Centre Hospitalier de l'Université de Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Marie-Amélie Lukaszewski', 'role': 'CONTACT', 'email': 'marie-amelie.lukaszewski@muhc.mcgill.ca', 'phone': '+1 514-934-1934', 'phoneExt': '35113'}, {'name': 'Kent MacKenzie, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MUHC - McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Denis Bilodeau', 'role': 'CONTACT', 'email': 'denisbilodeau@vitaamedical.com', 'phone': '5145728673'}], 'overallOfficials': [{'name': 'Mark Farber', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViTAA Medical Solutions', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Mark Farber', 'investigatorAffiliation': 'ViTAA Medical Solutions'}}}}