A Clinical Study of Iobitridol in Multislice CT Abdominal Angiography Indications

Guerbet4 个研究点分布在 2 个国家开始时间: 2006年8月1日最近更新: 2008年11月26日

适应症

试验速览

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

•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.

•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.

发起方

申办方类型

Industry

Loading locations...