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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)

C

Centre Hospitalier Universitaire de Nice

Status

Completed

Conditions

Endovascular Repair of Abdominal Aortic Aneurysm

Treatments

Procedure: Computed tomography scan versus color duplex ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT01230203
10-APN-01

Details and patient eligibility

About

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.

Enrollment

659 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

659 participants in 1 patient group

Computed tomography scan versus color duplex ultrasound
Other group
Treatment:
Procedure: Computed tomography scan versus color duplex ultrasound

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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