ENHANCEMENT OF THE LOWER EXTREMITIES COMPUTED TOMOGRAPHY: IOMERON®-400 VS VISIPAQUE™-320 (ELECTIV). - Elective

• Conditions: Patients with mild to moderate renal impairment who undergo clinically-indicated IV contrast-enhanced MDCTA (multi detector computed tomography angigraphy)scanning of the lower extremity arterial system, for suspected arterial disease, primarily narrowing or ischemia.

• Registration Number: EUCTR2004-000712-42-SE
• Lead Sponsor: Bracco Imaging S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-16
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

·provide written Informed Consent and are willing to comply with protocol requirements
·18 years of age or older,
·have a stable* baseline serum creatinine level of SCr=1.5-2.5 mg/dL and/or calculated CrCl = 10-60 mL/min.
*2 stable values: one within 6 months and one within 2 weeks before the examination,
·referred for a clinically-indicated contrast-enhanced MDCTA examination of the lower extremity arterial system.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·determined, by their physicians, that prophylactic medication is medically required for them to receive intravascular administration of an iodinated contrast agent,
·a history of hypersensitivity to iodine-containing compounds,
·severe congestive heart failure (class III-IV NYHA),
·suspicion of hyperthyroidism or thyroid malignancies,
·undergone any other radiological procedure utilizing x-ray contrast media from 72 hours before to 7 days after the administration of the study agent,
·uncontrolled diabetes,
·dialysis,
·unstable renal function/ serum creatinine levels/ acute renal failure,
·is a pregnant or lactating female. Exclude the possibility of pregnancy:
-by testing on site at the institution (serum or urine ßHCG) within 24 hours prior to the start of study agent administration
-by history (eg, tubal ligation or hysterectomy)
-post menopausal with a minimum 1 year without menses
(time of pregnancy test in relation to study agent administration must be recorded);
·previously entered in this study or having received an investigational drug within 30 days prior to admission to this study,
·any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data or achieving the study objectives, i.e.:
-drug dependence,
-psychiatric disorders, dementia, or other reasons for expected poor compliance with investigator’s instructions.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified