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OpenTrials
Completed

NCT Number: NCT01230203

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

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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Key information

Conditions

Endovascular Repair of Abdominal Aortic Aneurysm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'Amiens - Service de Chirurgie Vasculaire, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed tomography scan versus color duplex ultrasound

Procedure

Computed tomography scan versus color duplex ultrasound

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: ESSEA

Important dates

Study start
2010
Primary completion
2012
Study completion
2015
First posted
Oct 29, 2010
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.