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

Guerbet

Status and phase

Completed

Phase 4

Conditions

Diagnostic Imaging

Treatments

Drug: Iobitridol

Study type

Interventional

Funder types

Industry

Identifiers

ISO-44-009

Details and patient eligibility

About

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

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.