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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. The completion date has passed and the status has not been verified in more than two years.
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
CHU d'Amiens - Service de Chirurgie Vasculaire
Amiens, France
CHU d'Angers - Service de Chirurgie Vasculaire
Angers, France
CHU de Besançon - Service de Chirurgie Vasculaire
Besançon, France
CHU de Bordeaux - Service de Chirurgie Vasculaire
Bordeaux, France
CHU de Caen - Service de Chirurgie Vasculaire
Caen, France
CHU Clermont-ferrand - Service de Chirurgie Vasculaire
Clermont-ferrand, France
AP-HP Créteil - Service de chirurgie vasculaire
Créteil, France
CHU de Dijon - Service de Chirurgie Vasculaire
Dijon, France
CHU de Grenoble - Service de Chirurgie Vasculaire
Grenoble, France
CHRU Lille Service de Chirurgie Vasculaire
Lille, France
HCL - Service de Chirurgie Vasculaire
Lyon, France
AP-HM Service de Chirurgie vasculaire
Marseille, France
APHM - Hôpital Nord - Service de Chirurgie Vasculaire
Marseille, France
CHU de Montpellier - Service de Chirurgie Vasculaire
Montpellier, France
CHU de Nantes - Service de Chirurgie Vasculaire
Nantes, France
CHU de Nice - Service de chirurgie vasculaire
Nice, France
AP-HP - Pitié Salpétrière - Service de Chirurgie Vasculaire
Paris, France
CHU de Rouen - Service de Chirurgie Vasculaire
Rouen, France
CHU de St Etienne - Service de Chirurgie Vasculaire
St Etienne, France
CHU de Strasbourg - Service de Chirurgie Vasculaire
Strasbourg, France
CHU de Toulouse - Service de Chirurgie Vasculaire
Toulouse, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Hassen-Khofja Reda CHU de Nice - Service de Chirurgie Vasculaire
  More Information

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 December 06, 2016