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

Purpose

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.

Condition	Intervention
Endovascular Repair of Abdominal Aortic Aneurysm	Procedure: Computed tomography scan versus color duplex ultrasound

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm CT Scans Nuclear Scans

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:

Clinically significant abnormalities that require secondary intervention (coil embolization, endovascular intervention, surgical conversion) [ Time Frame: Between 1 week and 1 month ] [ Designated as safety issue: No ]
Clinically significant abnormalities that require secondary intervention (coil embolization, endovascular intervention, surgical conversion) :
- increasing aneurysm sac size (≥5mm),
- type I or type III endoleak,
- type II endoleak with an increasing aneurysm sac size (≥2mm)
- significant stenosis of a limb of the stentgraft (≥70%).

Secondary Outcome Measures:

All abnormalities, clinically significant or no [ Time Frame: Between 1 week and 1 month ] [ Designated as safety issue: No ]
All abnormalities, clinically significant or no:

All types of endoleak An increasing aneurysm sac size (≥1mm) Stenosis or thrombosis of limb of the stentgraft

Estimated Enrollment:	1000
Study Start Date:	October 2010
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Computed tomography scan versus color duplex ultrasound	Procedure: Computed tomography scan versus color duplex ultrasound Computed tomography scan versus color duplex ultrasound

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01230203

Locations

France
CHU d'Amiens - Service de Chirurgie Vasculaire	Recruiting
Amiens, France
Contact: REIX Thierry reix.thierry@chu-amiens.fr
Principal Investigator: REIX Thierry
CHU d'Angers - Service de Chirurgie Vasculaire	Recruiting
Angers, France
Contact: PICQUET Jean JePicquet@chu-angers.fr
Principal Investigator: PICQUET Jean
CHU de Besançon - Service de Chirurgie Vasculaire	Recruiting
Besançon, France
Contact: Rinckenbach Simon srinckenbach@chu-besancon.fr
Principal Investigator: Rinckenbach Simon
Sub-Investigator: LOPPINET Anca
CHU de Bordeaux - Service de Chirurgie Vasculaire	Recruiting
Bordeaux, France
Contact: Midy Dominique dominique.midy@chu-bordeaux.fr
Principal Investigator: Midy Dominique
Sub-Investigator: CHOUKROUN Marie-Luce
CHU de Caen - Service de Chirurgie Vasculaire	Recruiting
Caen, France
Contact: BERGER Ludovic berger-l@chu-caen.fr
Principal Investigator: BERGER Ludovic
Sub-Investigator: LEHELLO Claire
CHU Clermont-ferrand - Service de Chirurgie Vasculaire	Recruiting
Clermont-ferrand, France
Contact: ROSSET Eugénio erosset@chu-clermontferrand.fr
Principal Investigator: ROSSET Eugénio
Sub-Investigator: RAVOUX Mireille
AP-HP Créteil - Service de chirurgie vasculaire	Recruiting
Créteil, France
Contact: BECQUEMIN Jean-pierre pierre.becquemin@hmn.aphp.fr
Principal Investigator: BECQUEMIN Jean-pierre
Sub-Investigator: DESGRANGES Pascal
CHU de Dijon - Service de Chirurgie Vasculaire	Recruiting
Dijon, France
Contact: STEINMETZ Eric eric.steinmetz@chu-dijon.fr
Principal Investigator: STEINMETZ Eric
Sub-Investigator: TERRIAT Béatrice
CHU de Grenoble - Service de Chirurgie Vasculaire	Recruiting
Grenoble, France
Contact: MAGNE Jean-Luc jlmagne@chu-grenoble.fr
Principal Investigator: MAGNE Jean-Luc
CHRU Lille Service de Chirurgie Vasculaire	Recruiting
Lille, France
Contact: HAULON Stephane s-haulon@chru-lille.fr
Principal Investigator: Haullon Stephane
Sub-Investigator: Delkunder Ghislaine
HCL - Service de Chirurgie Vasculaire	Recruiting
Lyon, France
Contact: FEUGIER Patrick patrick.feugier@wanadoo.fr
Principal Investigator: FEUGIER Patrick
Sub-Investigator: BUREAU Pascale
AP-HM Service de Chirurgie vasculaire	Recruiting
Marseille, France
Contact: Magnan Pierre Edouard pemagnan@ap-hm.fr
Principal Investigator: Magnan Pierre Edouard
Sub-Investigator: SARLON Gabrielle
APHM - Hôpital Nord - Service de Chirurgie Vasculaire	Recruiting
Marseille, France
Contact: ALIMI Yves yves.alimi@ap-hm.fr
Principal Investigator: ALIMI Yves
Sub-Investigator: BARTHELEMY Pierre
CHU de Montpellier - Service de Chirurgie Vasculaire	Recruiting
Montpellier, France
Contact: Alric Pierre p-alric@chu-montpellier.fr
Principal Investigator: Alric Pierre
CHU de Nantes - Service de Chirurgie Vasculaire	Recruiting
Nantes, France
Contact: Goueffic Yann yann.goueffic@chu-nantes.fr
Principal Investigator: Goueffic Yann
CHU de Nice - Service de chirurgie vasculaire	Recruiting
Nice, France
Contact: Hassen-Khodja Reda 04 92 03 38 35 hassen-khodja.r@chu-nice.fr
Principal Investigator: Hassen-Khodja Reda
Sub-Investigator: bozzetto Catherine
Sub-Investigator: Baqué Jean
AP-HP - Pitié Salpétrière - Service de Chirurgie Vasculaire	Recruiting
Paris, France
Contact: KOSKAS Fabien fabien.koskas@psl.aphp.fr
Principal Investigator: KOSKAS Fabien
CHU de Rouen - Service de Chirurgie Vasculaire	Recruiting
Rouen, France
Contact: PLISSONNiER Didier didier.plissonnier@chu-rouen.fr
Principal Investigator: PLISSONNiER Didier
Sub-Investigator: LESTRAT Jean-Pierre
CHU de St Etienne - Service de Chirurgie Vasculaire	Recruiting
St Etienne, France
Contact: FAVRE Jean-Pierre j.pierre.favre@chu-st-etienne.fr
Principal Investigator: FAVRE Jean-Pierre
CHU de Strasbourg - Service de Chirurgie Vasculaire	Recruiting
Strasbourg, France
Contact: THAVEAU Fabien fabien.thaveau@chru-strasbourg.fr
Principal Investigator: THAVEAU Fabien
Sub-Investigator: ROUYER Olivier
CHU de Toulouse - Service de Chirurgie Vasculaire	Recruiting
Toulouse, France
Contact: CHAUFFOUR Xavier chaufour.x@chu-toulouse.fr
Principal Investigator: CHAUFFOUR Xavier
Sub-Investigator: Degeilh Maryse

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

Principal Investigator:

Hassen-Khofja Reda

CHU de Nice - Service de Chirurgie Vasculaire

More Information

No publications provided

Responsible Party:	Département de la recherche Clinique, Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:	NCT01230203 History of Changes
Other Study ID Numbers:	10-APN-01
Study First Received:	October 28, 2010
Last Updated:	October 28, 2010
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:

Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal

Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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