Endovascular Repair of Abdominal Aortic Aneurysm Clinical Trial
— ESSEAOfficial title:
Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study
| Verified date | November 2018 |
| Source | Centre Hospitalier Universitaire de Nice |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 659 |
| Est. completion date | June 12, 2015 |
| Est. primary completion date | November 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nice |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinically significant abnormalities that require secondary intervention (coil embolization, endovascular intervention, surgical conversion) | 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%). |
Between 1 week and 1 month | |
| Secondary | All abnormalities, clinically significant or 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 |
Between 1 week and 1 month |