Comparison of the diagnostic efficacy of Xenetix 350 and Iomeron 400, for visualisation of the aorta and abdominal vascular tree with 64-slices computed tomography

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001298-57-AT

Enrollment

310

Registered

2006-10-10

Start date

2006-06-04

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients scheduled for an abdominal MSCT angiography. MedDRA version: 9.0 Level: LLT Classification code 10063983

Interventions

Trade Name: XENETIX 350 MG I / ML Product Name: XENETIX 350 MG I/ML Pharmaceutical Form: Solution for injection INN or Proposed INN: IOBITRIDOL Concentration unit: mg/ml milligram(s)/millilitre Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female having reached legal majority age and up to 85 years included. - Patient scheduled for an aorta and abdominal arterial tree evaluation by MSCT, either for pretherapeutic 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. 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

Exclusion criteria: - Patient with overt compensated heart failure. - Patient with hemodynamic instability. - Patient with ESC/ESH grade 3 hypertension. - Patient with known renal failure. - Patient who have received diuretic or biguanide treatment during the 48 hours preceding the MSCT scan.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare, in a non-inferiority perspective, the diagnostic efficacy of Xenetix 350 and Iomeron 400 when injected for abdominal angiographic indications.;Secondary Objective: - To evaluate the global quality of the images in different vascular areas and vascular wall (and to assess the potential risk of artifacts). - To obtain an objective comparison of the quality of opacification. - To compare the clinical tolerance of both contrast media.;Primary end point(s): Assessment of the diagnostic efficacy of the MSCT examination with a 4-point evaluation scale grading the available information provided by images.	—

Measure

Time frame

Main Objective: To compare, in a non-inferiority perspective, the diagnostic efficacy of Xenetix 350 and Iomeron 400 when injected for abdominal angiographic indications.;Secondary Objective: - To evaluate the global quality of the images in different vascular areas and vascular wall (and to assess the potential risk of artifacts). - To obtain an objective comparison of the quality of opacification. - To compare the clinical tolerance of both contrast media.;Primary end point(s): Assessment of the diagnostic efficacy of the MSCT examination with a 4-point evaluation scale grading the available information provided by images.

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Countries

Austria, Belgium, Germany, Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026