Status:
COMPLETED
A Clinical Study of Iobitridol in Patients Undergoing Multislice Computed Tomography (CT) Abdominal Angiography
Lead Sponsor:
Guerbet
Conditions:
Diagnostic Imaging
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal angiography.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
End Date :
February 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00382317
Start Date
August 1 2006
End Date
February 1 2008
Last Update
November 26 2008
Active Locations (2)
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1
AKH
Vienna, Austria, 1090
2
CHU Charles Nicolle
Rouen, France, 76031