Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study (ESSEA)
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|ClinicalTrials.gov Identifier: NCT01230203|
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : November 8, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||659 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Computed tomography scan versus color duplex ultrasound||
Procedure: Computed tomography scan versus color duplex ultrasound
Computed tomography scan versus color duplex ultrasound
- 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%).
- 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
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
|Principal Investigator:||Hassen-Khofja Reda||CHU de Nice - Service de Chirurgie Vasculaire|