Comparison of the diagnostic efficacy of Xenetix 350 and Iomeron 400, for visualisation of the aorta and abdominal vascular tree with 64-slices computed tomography

Conditions: Patients scheduled for an abdominal MSCT angiography.
MedDRA version: 9.0Level: LLTClassification code 10063983

Registration Number: EUCTR2006-001298-57-DE

Lead Sponsor: GUERBET

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 310

Inclusion Criteria

- Male or female having reached legal majority age and up to 85 years included.
- Patient scheduled for an aorta and abdominal arterial tree evaluation by MSCT, either for pretherapeutic evaluation or for post-surgical control or follow-up (including patients with prosthetic vascular material).
- Female of childbearing potential must have effective contraception (contraceptive pill or Intra-Uterine Device), or be surgically sterilised, or post-menopausal (minimum 12 months amenorrhea) or must have a documented negative urine and/or blood pregnancy test at screening.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patient with overt compensated heart failure.
- Patient with hemodynamic instability.
- Patient with ESC/ESH grade 3 hypertension.
- Patient with known renal failure.
- Patient who have received diuretic or biguanide treatment during the 48 hours preceding the MSCT scan.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare, in a non-inferiority perspective, the diagnostic efficacy of Xenetix 350 and Iomeron 400 when injected for abdominal angiographic indications.;Secondary Objective: - To evaluate the global quality of the images in different vascular areas and vascular wall (and to assess the potential risk of artifacts).<br>- To obtain an objective comparison of the quality of opacification.<br>- To compare the clinical tolerance of both contrast media.;Primary end point(s): Assessment of the diagnostic efficacy of the MSCT examination with a 4-point evaluation scale grading the available information provided by images.

Secondary Outcome Measures