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Completed

NCT Number: NCT00382317

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

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

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AKH, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iobitridol

Drug

Sponsors and collaborators

Lead sponsor

Guerbet

Industry

Registry information

Official study title

A Clinical Study of Iobitridol in Multislice CT Abdominal Angiography Indications

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 29, 2006
Registry last updated
Nov 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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