Control Post Endovascular Treatment of Aortic Aneurisms Through Magnetic Resonance and Ultrasound (SAFEVAR)

NCT03439423 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2022-09-13

No results posted yet for this study

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

Conditions

  • Abdominal Aortic Aneurism

Interventions

RADIATION

CT with contrast agent

DIAGNOSTIC_TEST

MR without contrast agent

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

DIAGNOSTIC_TEST

Color-Doppler Ultrasound

OTHER

Questionnaire

regarding their perception of examinations

Sponsors & Collaborators

  • IRCCS Policlinico S. Donato

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-09
Primary Completion
2022-09-12
Completion
2022-09-12

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03439423 on ClinicalTrials.gov