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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01230203
First received: October 28, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  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:


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 April 15, 2014