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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01230203
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Tracking Information
First Submitted Date  ICMJE October 28, 2010
First Posted Date  ICMJE October 29, 2010
Last Update Posted Date November 8, 2018
Actual Study Start Date  ICMJE December 16, 2010
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
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%).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study
Official Title  ICMJE Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study
Brief 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.

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Endovascular Repair of Abdominal Aortic Aneurysm
Intervention  ICMJE Procedure: Computed tomography scan versus color duplex ultrasound
Computed tomography scan versus color duplex ultrasound
Study Arms  ICMJE Computed tomography scan versus color duplex ultrasound
Intervention: Procedure: Computed tomography scan versus color duplex ultrasound
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2018)
659
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2010)
1000
Actual Study Completion Date  ICMJE June 12, 2015
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01230203
Other Study ID Numbers  ICMJE 10-APN-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Nice
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nice
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hassen-Khofja Reda CHU de Nice - Service de Chirurgie Vasculaire
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP