Clinical trial NCT01230203: Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study
Official title: Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endovascular Repair of Abdominal Aortic Aneurysm
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2010-10-29
Enrollment: 659
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Patients 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.


Eligibility criteria: Inclusion Criteria:

* Patients who were followed after EVAR, whatever the trademark and the model of the stentgraft (bi-iliac or mono-iliac)
* Age \> 18 years old
* Patient with social insurance
* Signature of informed consent

Exclusion Criteria:

* patients who underwent EVAR with a fenestrated or branched stentgraft
* Obese patients (BMI \> 30)
* Patients with severe renal insufficiency (Creatinine Clearance \< 30 ml/mn)
* Patients who can't practice both an CT scan with iode injection and duplex ultrasound test over a period of one month

Primary outcomes:
measure: Clinically significant abnormalities that require secondary intervention (coil embolization, endovascular intervention, surgical conversion)
timeFrame: Between 1 week and 1 month
Secondary outcomes:
measure: All abnormalities, clinically significant or no
timeFrame: Between 1 week and 1 month
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens - Service de Chirurgie Vasculaire
city: Angers
country: France
facility: CHU d'Angers - Service de Chirurgie Vasculaire
city: Besançon
country: France
facility: CHU de Besançon - Service de Chirurgie Vasculaire
city: Bordeaux
country: France
facility: CHU de Bordeaux - Service de Chirurgie Vasculaire
city: Caen
country: France
facility: CHU de Caen - Service de Chirurgie Vasculaire
city: Clermont-ferrand
country: France
facility: CHU Clermont-ferrand - Service de Chirurgie Vasculaire
city: Créteil
country: France
facility: AP-HP Créteil - Service de chirurgie vasculaire
city: Dijon
country: France
facility: CHU de Dijon - Service de Chirurgie Vasculaire
city: Grenoble
country: France
facility: CHU de Grenoble - Service de Chirurgie Vasculaire
city: Lille
country: France
facility: CHRU Lille Service de Chirurgie Vasculaire
city: Lyon
country: France
facility: HCL - Service de Chirurgie Vasculaire
city: Marseille
country: France
facility: AP-HM Service de Chirurgie vasculaire
city: Marseille
country: France
facility: APHM - Hôpital Nord - Service de Chirurgie Vasculaire
city: Montpellier
country: France
facility: CHU de Montpellier - Service de Chirurgie Vasculaire
city: Nantes
country: France
facility: CHU de Nantes - Service de Chirurgie Vasculaire
city: Nice
country: France
facility: CHU de Nice - Service de chirurgie vasculaire
city: Paris
country: France
facility: AP-HP - Pitié Salpétrière - Service de Chirurgie Vasculaire
city: Rouen
country: France
facility: CHU de Rouen - Service de Chirurgie Vasculaire
city: St Etienne
country: France
facility: CHU de St Etienne - Service de Chirurgie Vasculaire
city: Strasbourg
country: France
facility: CHU de Strasbourg - Service de Chirurgie Vasculaire
city: Toulouse
country: France
facility: CHU de Toulouse - Service de Chirurgie Vasculaire
Study officials:
affiliation: CHU de Nice - Service de Chirurgie Vasculaire
name: Hassen-Khofja Reda
role: PRINCIPAL_INVESTIGATOR
References:
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.