Comparison of the diagnostic efficacy of Xenetix 350 and Iomeron 400, for visualization of the aorta and abdominal vascular tree with 64-slices computed tomography. - ISO-44-009

• Conditions: Patients 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).; MedDRA version: 9.1Level: LLTClassification code 10052677Term: Vascular imaging

• Registration Number: EUCTR2006-001298-57-IT
• Lead Sponsor: GUERBET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-14
• Last Update Posted: 19 March 2012

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. - 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). - Patient having provided his written informed consent to participate in the trial.
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

- Patients with overt non compensate heart failure. - Patients with hemodynamic instability. - Patients with ESC/ESH grade 3 hypertension. - Patients with known severe renal failure. - Patients who have received diuretic or biguanide treatment during the 48 hours preceding the MSCT scan. - Patients with known thyreotoxicosis. - Patients with history of immediate or delayed major hypersensitivity reaction to a iodinated contrast media. - Patients having received or planned to receive an iodinated contrast sagent during 48 hours preceding the MSCT scan.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified