Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-30 @ 5:43 PM
Study NCT ID:
NCT01230203
Status:
COMPLETED
Last Update Posted:
2018-11-08
First Post:
2010-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 659}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2015-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-07', 'studyFirstSubmitDate': '2010-10-28', 'studyFirstSubmitQcDate': '2010-10-28', 'lastUpdatePostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinically significant abnormalities that require secondary intervention (coil embolization, endovascular intervention, surgical conversion)', 'timeFrame': 'Between 1 week and 1 month', 'description': 'Clinically significant abnormalities that require secondary intervention (coil embolization, endovascular intervention, surgical conversion) :\n\n* increasing aneurysm sac size (≥5mm),\n* type I or type III endoleak,\n* type II endoleak with an increasing aneurysm sac size (≥2mm)\n* significant stenosis of a limb of the stentgraft (≥70%).'}], 'secondaryOutcomes': [{'measure': 'All abnormalities, clinically significant or no', 'timeFrame': 'Between 1 week and 1 month', 'description': 'All abnormalities, clinically significant or no:\n\nAll types of endoleak An increasing aneurysm sac size (≥1mm) Stenosis or thrombosis of limb of the stentgraft'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endovascular Repair of Abdominal Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '32507018', 'type': 'DERIVED', 'citation': 'Jean-Baptiste E, Feugier P, Cruzel C, Sarlon-Bartoli G, Reix T, Steinmetz E, Chaufour X, Chavent B, Salomon du Mont L, Ejargue M, Maurel B, Spear R, Midy D, Thaveau F, Desgranges P, Rosset E, Hassen-Khodja R; Association Universitaire de Recherche en Chirurgie Vasculaire. Computed Tomography-Aortography Versus Color-Duplex Ultrasound for Surveillance of Endovascular Abdominal Aortic Aneurysm Repair: A Prospective Multicenter Diagnostic-Accuracy Study (the ESSEA Trial). Circ Cardiovasc Imaging. 2020 Jun;13(6):e009886. doi: 10.1161/CIRCIMAGING.119.009886. Epub 2020 Jun 8.'}]}, 'descriptionModule': {'briefSummary': 'Cumulative radiation dose, cost, contrast induced nephrotoxicity and increased demand for computed tomography aortography (CTA) suggest that duplex ultrasonoraphy (DU) may be an alternative to CTA-based surveillance. The investigators compared CTA with DU during endovascular aneurysm repair (EVAR) follow-up.\n\nPatients undergoing EVAR have radiological follow-up data entered in a prospectively multicenter database. The gold standard test for endoleak detection was CTA. DU interpretation was performed independently of CTA and vice versa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who were followed after EVAR, whatever the trademark and the model of the stentgraft (bi-iliac or mono-iliac)\n* Age \\> 18 years old\n* Patient with social insurance\n* Signature of informed consent\n\nExclusion Criteria:\n\n* patients who underwent EVAR with a fenestrated or branched stentgraft\n* Obese patients (BMI \\> 30)\n* Patients with severe renal insufficiency (Creatinine Clearance \\< 30 ml/mn)\n* Patients who can't practice both an CT scan with iode injection and duplex ultrasound test over a period of one month"}, 'identificationModule': {'nctId': 'NCT01230203', 'acronym': 'ESSEA', 'briefTitle': 'Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study', 'orgStudyIdInfo': {'id': '10-APN-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Computed tomography scan versus color duplex ultrasound', 'interventionNames': ['Procedure: Computed tomography scan versus color duplex ultrasound']}], 'interventions': [{'name': 'Computed tomography scan versus color duplex ultrasound', 'type': 'PROCEDURE', 'description': 'Computed tomography scan versus color duplex ultrasound', 'armGroupLabels': ['Computed tomography scan versus color duplex ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'facility': "CHU d'Amiens - Service de Chirurgie Vasculaire", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Angers', 'country': 'France', 'facility': "CHU d'Angers - Service de Chirurgie Vasculaire", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Besançon', 'country': 'France', 'facility': 'CHU de Besançon - Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux - Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU de Caen - Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-ferrand - Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Créteil', 'country': 'France', 'facility': 'AP-HP Créteil - Service de chirurgie vasculaire', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Dijon', 'country': 'France', 'facility': 'CHU de Dijon - Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble - Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lille', 'country': 'France', 'facility': 'CHRU Lille Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': 'HCL - Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'AP-HM Service de Chirurgie vasculaire', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'APHM - Hôpital Nord - Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier - Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes - Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice - Service de chirurgie vasculaire', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Paris', 'country': 'France', 'facility': 'AP-HP - Pitié Salpétrière - Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU de Rouen - Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de St Etienne - Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU de Strasbourg - Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Toulouse - Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Hassen-Khofja Reda', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Nice - Service de Chirurgie Vasculaire'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}