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Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study

NCT ID: NCT01230203

Last Updated: 2018-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

659 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-16

Study Completion Date

2015-06-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Endovascular Repair of Abdominal Aortic Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Computed tomography scan versus color duplex ultrasound

Group Type OTHER

Computed tomography scan versus color duplex ultrasound

Intervention Type PROCEDURE

Computed tomography scan versus color duplex ultrasound

Interventions

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Computed tomography scan versus color duplex ultrasound

Computed tomography scan versus color duplex ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hassen-Khofja Reda

Role: PRINCIPAL_INVESTIGATOR

CHU de Nice - Service de Chirurgie Vasculaire

Locations

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CHU d'Amiens - Service de Chirurgie Vasculaire

Amiens, , France

Site Status

CHU d'Angers - Service de Chirurgie Vasculaire

Angers, , France

Site Status

CHU de Besançon - Service de Chirurgie Vasculaire

Besançon, , France

Site Status

CHU de Bordeaux - Service de Chirurgie Vasculaire

Bordeaux, , France

Site Status

CHU de Caen - Service de Chirurgie Vasculaire

Caen, , France

Site Status

CHU Clermont-ferrand - Service de Chirurgie Vasculaire

Clermont-Ferrand, , France

Site Status

AP-HP Créteil - Service de chirurgie vasculaire

Créteil, , France

Site Status

CHU de Dijon - Service de Chirurgie Vasculaire

Dijon, , France

Site Status

CHU de Grenoble - Service de Chirurgie Vasculaire

Grenoble, , France

Site Status

CHRU Lille Service de Chirurgie Vasculaire

Lille, , France

Site Status

HCL - Service de Chirurgie Vasculaire

Lyon, , France

Site Status

AP-HM Service de Chirurgie vasculaire

Marseille, , France

Site Status

APHM - Hôpital Nord - Service de Chirurgie Vasculaire

Marseille, , France

Site Status

CHU de Montpellier - Service de Chirurgie Vasculaire

Montpellier, , France

Site Status

CHU de Nantes - Service de Chirurgie Vasculaire

Nantes, , France

Site Status

CHU de Nice - Service de chirurgie vasculaire

Nice, , France

Site Status

AP-HP - Pitié Salpétrière - Service de Chirurgie Vasculaire

Paris, , France

Site Status

CHU de Rouen - Service de Chirurgie Vasculaire

Rouen, , France

Site Status

CHU de St Etienne - Service de Chirurgie Vasculaire

Saint-Etienne, , France

Site Status

CHU de Strasbourg - Service de Chirurgie Vasculaire

Strasbourg, , France

Site Status

CHU de Toulouse - Service de Chirurgie Vasculaire

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 32507018 (View on PubMed)

Other Identifiers

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10-APN-01

Identifier Type: -

Identifier Source: org_study_id

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