Endovascular Repair of Abdominal Aortic AneurysmESSEANCT01230203
Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study
A study testing Computed tomography scan versus color duplex ultrasound in people with Endovascular Repair of Abdominal Aortic Aneurysm, run by Centre Hospitalier Universitaire de Nice at 21 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endovascular Repair of Abdominal Aortic Aneurysm
- What is being tested?
- Computed tomography scan versus color duplex ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 659 participants
- Where
- 21 sitesFrance
- Study dates
- 16 Dec 2010to 12 Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
CHU d'Amiens - Service de Chirurgie Vasculaire
Amiens
CHU d'Angers - Service de Chirurgie Vasculaire
Angers
CHU de Besançon - Service de Chirurgie Vasculaire
Besançon
CHU de Bordeaux - Service de Chirurgie Vasculaire
Bordeaux
CHU de Caen - Service de Chirurgie Vasculaire
Caen
CHU Clermont-ferrand - Service de Chirurgie Vasculaire
Clermont-Ferrand
AP-HP Créteil - Service de chirurgie vasculaire
Créteil
CHU de Dijon - Service de Chirurgie Vasculaire
Dijon
CHU de Grenoble - Service de Chirurgie Vasculaire
Grenoble
CHRU Lille Service de Chirurgie Vasculaire
Lille
HCL - Service de Chirurgie Vasculaire
Lyon
AP-HM Service de Chirurgie vasculaire
Marseille
APHM - Hôpital Nord - Service de Chirurgie Vasculaire
Marseille
CHU de Montpellier - Service de Chirurgie Vasculaire
Montpellier
CHU de Nantes - Service de Chirurgie Vasculaire
Nantes
CHU de Nice - Service de chirurgie vasculaire
Nice
AP-HP - Pitié Salpétrière - Service de Chirurgie Vasculaire
Paris
CHU de Rouen - Service de Chirurgie Vasculaire
Rouen
CHU de St Etienne - Service de Chirurgie Vasculaire
Saint-Etienne
CHU de Strasbourg - Service de Chirurgie Vasculaire
Strasbourg
CHU de Toulouse - Service de Chirurgie Vasculaire
Toulouse
About this 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.
- Being tested
- Computed tomography scan versus color duplex ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography scan versus color duplex ultrasoundProcedure or surgery
Computed tomography scan versus color duplex ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Computed tomography scan versus color duplex ultrasound | Other | Not described Receives: Procedure: Computed tomography scan versus color duplex ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: Between 1 week and 1 month
Secondary outcomes (1)
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
Measured: Between 1 week and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study start16 Dec 2010
- Primary completionNov 2012
- Study completion12 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endovascular Repair of Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hassen-Khofja Reda, Principal investigator, CHU de Nice - Service de Chirurgie Vasculaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230203
- Sponsor's protocol ID
- 10-APN-01
- Acronym
- ESSEA
- Status last verified
- Mar 2026
- First submitted
- 28 Oct 2010
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Jean-Baptiste E, Feugier P, Cruzel C, Sarlon-Bartoli G, Reix T, Steinmetz E, Chaufour X, Chavent B, Salomon du Mont L, Ejargue M, Maurel B, Spear R, Midy D, Thaveau F, Desgranges P, Rosset E, Hassen-Khodja R; Association Universitaire de Recherche en Chirurgie Vasculaire. Computed Tomography-Aortography Versus Color-Duplex Ultrasound for Surveillance of Endovascular Abdominal Aortic Aneurysm Repair: A Prospective Multicenter Diagnostic-Accuracy Study (the ESSEA Trial). Circ Cardiovasc Imaging. 2020 Jun;13(6):e009886. doi: 10.1161/CIRCIMAGING.119.009886. Epub 2020 Jun 8.
PubMed 32507018
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT01230203
- Acronym / sponsor ID
- ESSEA / 10-APN-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 16 Dec 2010 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- 12 Jun 2015 (actual)
- First posted
- 29 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computed tomography scan versus color duplex ultrasound | Other | Procedure: Computed tomography scan versus color duplex ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomography scan versus color duplex ultrasoundComputed tomography scan versus color duplex ultrasound | Procedure or surgery | Computed tomography scan versus color duplex ultrasound |
Primary outcome
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%).
1 secondary outcome
All abnormalities, clinically significant or no
Time frame: Between 1 week and 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Results publication: PubMed 32507018Jean-Baptiste E, Feugier P, Cruzel C, Sarlon-Bartoli G, Reix T, Steinmetz E, Chaufour X, Chavent B, Salomon du Mont L, Ejargue M, Maurel B, Spear R, Midy D, Thaveau F, Desgranges P, Rosset E, Hassen-Khodja R; Association Universitaire de Recherche en Chirurgie Vasculaire. Computed Tomography-Aortography Versus Color-Duplex Ultrasound for Surveillance of Endovascular Abdominal Aortic Aneurysm Repair: A Prospective Multicenter Diagnostic-Accuracy Study (the ESSEA Trial). Circ Cardiovasc Imaging. 2020 Jun;13(6):e009886. doi: 10.1161/CIRCIMAGING.119.009886. Epub 2020 Jun 8.
Related trials for Endovascular Repair of Abdominal Aortic Aneurysm
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Recruiting
PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm
Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Recruiting
Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)
Thoracoabdominal Aortic Aneurysm, Endovascular Repair
Not yet recruitingObservational study
Deep-learning Predictors of Abdominal Aortic Aneurysm Enlargement in Type II Endoleaks After Endovascular Aortic Repair: The RADAR Study
Type II Endoleak, Abdominal Aortic Aneurysm Enlargement
Not yet recruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassen-Khofja Reda principal investigator
CHU de Nice - Service de Chirurgie Vasculaire
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed tomography scan versus color duplex ultrasound in people with Endovascular Repair of Abdominal Aortic Aneurysm, run by Centre Hospitalier Universitaire de Nice at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant abnormalities that require secondary intervention (coil embolization, endovascular intervention, surgical conversion) (time frame: Between 1 week and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01230203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.