A Clinical Study of Iobitridol in Patients Undergoing Multislice Computed Tomography (CT) Abdominal Angiography

Phase 4

Completed

• Conditions: Diagnostic Imaging

• Registration Number: NCT00382317
• Lead Sponsor: Guerbet

Brief Summary

This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal angiography.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-09-28
• Study First Submitted QC: 2006-09-28
• Study First Posted: 2006-09-29
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-25
• Last Update Posted: 2008-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 pre-therapeutic 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.

Exclusion Criteria

• Patients with overt non-compensated heart failure.
• Patients with hemodynamic instability.
• Patients with ESC (European Society of Cardiology)/ESH (European Society of Hypertension) grade 3 hypertension (SBP [systolic blood pressure) over or equal to 180 mm Hg or DBP [diastolic blood pressure] over or equal to 110 mm Hg)
• Patients with known severe renal failure (defined as creatinine clearance < 30 ml/min as calculated by the Cockroft and Gault formula).
• 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 iodinated contrast media.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (2)

AKH; 🇦🇹 Vienna, Austria

CHU Charles Nicolle; 🇫🇷 Rouen, France