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

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

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

Official Title

Controllo Dopo Trattamento Endovascolare di Aneurismi Aortici Mediante Risonanza Magnetica Senza Mezzo di Contrasto ed Ecografia Con Color-doppler: Accuratezza Diagnostica, Analisi Costo-efficacia e Impatto Sul Management Del Paziente

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

Detailed Description

      In this prospective observational study, 250 patients who underwent EVAR will be studied.
      They will be enrolled after referral for a CT with contrast agent at IRCCS Policlinico San
      Donato or at ASST Santi Paolo e Carlo. Those with absolute contraindications to RM will be
      excluded.

      All enrolled subjects will undergo MR with contrast agent and color-Doppler ultrasound after
      CT. Before and after each examination, they will be submitted a questionnaire to evaluate
      their perception towards the former, and both costs and exposure deriving from such
      examinations will be evaluated along with patients' responses. Moreover, both CT and MR along
      with color-Doppler ultrasound will be analyzed with regards to human resources management,
      operational management, patients' clinical workflow and organization.

      All CT examinations will be independently evaluated by two radiologists with 4- and 8-year
      expertise in thoracic or abdominal CT. Results obtained from CT examinations will be used as
      a reference standard using the "worst case scenario" method: if either reader reported
      endoleak, the CT will be considered positive. The more experienced reader will anonymously
      and randomly repeat CT evaluation after 1 month.

      For CMR examinations, a 15-minute protocol will be used on a 1.5-T device. The following
      sequences will be performed:

        -  steady state free-precession (true-FISP)

        -  half-Fourier single shot spin-echo (HASTE) All examinations will be independently and
           blindly evaluated by the same two radiologists as CT examinations, and they will be
           considered positive if areas (even smaller than 5 mm) of alterate signal in comparison
           to surrounding muscle in the same slice are present inside the aneurismatic sac. The
           more experienced reader will anonymously and randomly repeat CT evaluation after 1
           month.

      Color-Doppler ultrasound will be performed with a 1-5 MHz probe, by a radiologist with 7-year
      expertise in aortic ultrasound, blinded to MR and CT results. Ultrasound images will be
      evaluated both directly and through spectral flow study.

      The sample size was calculated assuming an alpha error of 5%, 90% power and 10% endoleak
      prevalence. In order to prove a negative predictive value of MR without contrast agent and
      color-Doppler ultrasound not inferior to 90%, 250 patients should be enrolled.

Study Type

Observational

Primary Outcome

Sensitivity and negative predictive value

Secondary Outcome

 Efficacy of the two diagnostic approaches

Condition

Abdominal Aortic Aneurism

Intervention

CT with contrast agent

Study Arms / Comparison Groups

 Patients who underwent EVAR
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Radiation

Estimated Enrollment

250

Start Date

March 9, 2016

Completion Date

September 12, 2022

Primary Completion Date

September 12, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  patients older than 18

          -  informed written consent

          -  with either thoracic or abdominal aortic endoprosthesis

        Exclusion Criteria:

          -  lack of informed written consent

          -  patients with absolute contraindications to magnetic resonance imaging

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Italy

Location Countries

Italy

Administrative Informations

NCT ID

NCT03439423

Organization ID

SAFEVAR_v02

Responsible Party

Principal Investigator

Study Sponsor

IRCCS Policlinico S. Donato

Study Sponsor

, ,

Verification Date

September 2022