"Evaluation of efficacy and accuracy of a CTA low dose protocol for Pazients with EVAR"

"Evaluation of efficacy and accuracy of a CTA low dose protocol for Pazients with EVAR" - EVARBD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000692-24-IT

Enrollment

Registered

2021-06-08

Start date

2017-04-05

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with aortic aneurism who underwent to endovascular repair of aortic aneurism. MedDRA version: 20.0 Level: LLT Classification code 10000051 Term: Abdominal aneurysm System Organ Class: 100000004866

Interventions

Trade Name: IOMERON - 400 MG/ML SOLUZIONE INIETTABILE FLACONCINO 500 ML Product Name: IOMERON 400 Pharmaceutical Form: Solution for infusion INN or Proposed INN: IOMEPROLO CAS Number: 78649-41-9 Curre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients in follow-up for EVAR Patient with EVAR waiting for re-procedure Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Esclusion criteria: Allergy to contrast media Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the quality and thaaccuracy of angiography with compuetr tomography (CTA) using low dose of contrast and low dose of radiation. ;Secondary Objective: 1. Evaluation of subjective qualitative and quantitative analysis with low dose protocol compare to the standard. 2. Evaluation of diagnostic accuracy of low dose protocol. 3.Evaluation of dose reduction in low dose protocol.;Primary end point(s): To evaluate the quality and thaaccuracy of angiography with compuetr tomography (CTA) using low dose of contrast and low dose of radiation. ;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: To evaluate the quality and thaaccuracy of angiography with compuetr tomography (CTA) using low dose of contrast and low dose of radiation. ;Secondary Objective: 1. Evaluation of subjective qualitative and quantitative analysis with low dose protocol compare to the standard. 2. Evaluation of diagnostic accuracy of low dose protocol. 3.Evaluation of dose reduction in low dose protocol.;Primary end point(s): To evaluate the quality and thaaccuracy of angiography with compuetr tomography (CTA) using low dose of contrast and low dose of radiation. ;Timepoint(s) of evaluation of this end point: 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Evaluation of subjective qualitative and quantitative analysis with low dose protocol compare to the standard. 2. Evaluation of diagnostic accuracy of low dose protocol. 3.Evaluation of dose reduction in low dose protocol.;Timepoint(s) of evaluation of this end point: 6 months	—

Countries

Italy

Contacts

Public ContactUO Radiologia PO S. Donato

AZIENDA USL 8 AREZZO

zini.chiara@gmail.com3396946717

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026