NCT03439423

Brief Summary

The aims of this study are to verify non-inferiority of magnetic resonance (MR) without contrast agent associated to color-Doppler ultrasound for the diagnosis of endoleaks after endovascular aortic repair (EVAR), to evaluate both the economical and biological cost-effectiveness of such diagnostic algorithm as an alternative to computed tomography (CT) with contrast agent, and to analyze its impact on both patients work-flow and infrastructure logistics

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

6.5 years

First QC Date

February 2, 2018

Last Update Submit

September 12, 2022

Conditions

Abdominal Aortic Aneurism

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and negative predictive value

    CT exams with contrast agent will be interpreted by 2 independent and blinded radiologists. The results of enhanced CT will be used as reference standard basing to "worst case scenario" method, i.e. it will be considered positive when one or both readers will report the presence of endoleak. Moreover, in the same way, the most expert reader will repeat the reading after 1 month compared to the first reading. Enhanced 1.5-T MRI will be conducted using true-FISP and HASTE sequences. The same 2 readers will evaluate the exams comparing to the previous CT exams. Images will be considered positive for the presence of endoleak if inside the aneurysmal sac excluded there will be an area of altered signal compared to adjacent muscles displayed in the same layers. The most experienced reader will repeat the exam reading 1 month later. The 1,5 MHz Color-Doppler ultrasound will be performed by a radiologist with 7 y of experience in vascular ultrasound of the aorta, blinded to the enhanced CT.

    2 year

Secondary Outcomes (6)

  • Efficacy of the two diagnostic approaches

    2 year

  • Patient's perception

    2 year

  • Economic costs

    2 year

  • Patient management

    2 year

  • Involvement of professionals

    2 year

  • +1 more secondary outcomes

Study Arms (1)

Patients who underwent EVAR

Radiation: CT with contrast agentDiagnostic Test: MR without contrast agentDiagnostic Test: Color-Doppler UltrasoundOther: Questionnaire

Interventions

CT with contrast agentRADIATION
Patients who underwent EVAR
MR without contrast agentDIAGNOSTIC_TEST

on 1.5-T unit, with the following sequences: * steady-state free-precession (true-FISP) * half-Fourier single shot spin-echo (HASTE)

Patients who underwent EVAR
Color-Doppler UltrasoundDIAGNOSTIC_TEST
Patients who underwent EVAR
QuestionnaireOTHER

regarding their perception of examinations

Patients who underwent EVAR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent endovascular aortic repair

You may qualify if:

  • patients older than 18
  • informed written consent
  • with either thoracic or abdominal aortic endoprosthesis

You may not qualify if:

  • lack of informed written consent
  • patients with absolute contraindications to magnetic resonance imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

MeSH Terms

Interventions

Contrast MediaSurveys and Questionnaires

Intervention Hierarchy (Ancestors)

Diagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Radiology Department

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 20, 2018

Study Start

March 9, 2016

Primary Completion

September 12, 2022

Study Completion

September 12, 2022

Last Updated

September 13, 2022

Record last verified: 2022-09

Locations

IT(1)