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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01230203
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.


Condition or disease Intervention/treatment Phase
Endovascular Repair of Abdominal Aortic Aneurysm Procedure: Computed tomography scan versus color duplex ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 659 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : December 16, 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : June 12, 2015


Arm Intervention/treatment
Computed tomography scan versus color duplex ultrasound Procedure: Computed tomography scan versus color duplex ultrasound
Computed tomography scan versus color duplex ultrasound




Primary Outcome Measures :
  1. Clinically significant abnormalities that require secondary intervention (coil embolization, endovascular intervention, surgical conversion) [ Time Frame: Between 1 week and 1 month ]

    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 :
  1. All abnormalities, clinically significant or no [ Time Frame: Between 1 week and 1 month ]

    All abnormalities, clinically significant or no:

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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230203


Locations
Show Show 21 study locations
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Hassen-Khofja Reda CHU de Nice - Service de Chirurgie Vasculaire
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01230203    
Other Study ID Numbers: 10-APN-01
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases