A multicentre, phase 3, open label study to assess the efficacy and safety of 0.1 mmol/kg Omniscan™ (gadodiamide injection) for Magnetic Resonance Angiography (MRA) of the aorto-iliac arteries

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000994-69-AT

Enrollment

192

Registered

2004-10-07

Start date

2004-11-11

Completion date

Unknown

Last updated

2013-04-22

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

Conditions

Suspected or proven chronic PAOD predominantly located in the aorto-iliac region of Fontaine Stages IIb to IV (ie, Rutherford Stages I3-III), or presents with an ankle brachial pressure index of <0.70 (measured no more than 3 months prior to screening) MedDRA version: 7.0 Level: LLT Classification code 10062585

Interventions

Trade Name: Omniscan Product Name: Omniscan 0.5mmol/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: Gadodiamide Concentration unit: mmol/ml millimole(s)/millilitre Concentration ty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)The subject has suspected or proven chronic PAOD predominantly located in the aorto-iliac region of Fontaine Stages IIb to IV (ie, Rutherford Stages I3-III), or presents with an ankle brachial pressure index of =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: (1)The subject has a known hypersensitivity to either conventional X-ray or gadolinium-based MR contrast media including, but not restricted to, the investigational product. (2)The subject is lactating. (3)The subject is pregnant as defined by a serum or urine ß-HCG pregnancy test obtained within 24 hours before administration of the investigational product. (4)The subject received or is scheduled to receive MRI contrast medium within 24 hours prior to or less than 24 hours after administration of the investigational product. (5)The subject received or is scheduled to receive X-ray contrast medium within 24 hours prior to or less than 24 hours after administration of the investigational product. (6)The subject received an investigational product other than OMNISCAN within 30 days prior to OMNISCAN administration or will receive an investigational product within the follow-up period proposed for this study. (7)The subject presents any clinically active, serious, life-threatening disease with a life expectancy of less than 6 months. (8)The subject has a serum creatinine value of >3.5 mg/dL (309.4 µmol/L). (9)The subject has previously been included in this study. (10)The subject has a contra-indication for MRI according to accepted clinical guidelines. (11) The subject has metal implants and/or stents in the aorto-iliac region and/or hip replacement.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): To determine the efficacy of 0.1 mmol/kg OMNISCAN for 3 dimensional contrast-enhanced magnetic resonance angiography (3D CE MRA) compared to 2 dimensional time-of-flight (2D TOF) MRA in the identification of the presence or absence of main haemodynamically relevant stenoses (ie, =50% or occlusion) within turbulent flow arteries of the aorto-iliac region. Intra-arterial digital subtraction angiography (IA DSA) will be used as the standard of truth. Co-primary endpoints The following primary efficacy endpoints will be evaluated simultaneously for each MRA reader: (1)Difference in sensitivity between 3D CE MRA and 2D TOF MRA in the identification of the main haemodynamically relevant stenosis (ie, =50% or occlusion) on a subject level across the 7 aorto iliac arterial segments with IA DSA as the standard of truth. The main stenosis is defined as the stenosis with the highest grade (ie, percentage decrease in vessel diameter) in one of the 7 vessel segments as determined by the IA DSA blinded image evaluation (BIE). (2)Difference in specificity between 3D CE MRA and 2D TOF MRA in the identification of a haemodynamically relevant stenosis (ie, =50% or occlusion) based on all of the 7 aorto-iliac arterial segments combined with IA DSA as the standard of truth. All vessel segments across all subjects which are determined to have no haemodynamically relevant stenosis by the IA DSA BIE will be considered for the calculation of specificity. The results of 3 independent blinded MRA readers in each subject will be compared separately to the IA DSA findings (read by 2 blinded DSA readers independently - in case of a mismatch between the 2 readers, the readers will be brought together, evaluate the images together and reach consensus). ;Main Objective: To determine the efficacy of 0.1 mmol/kg OMNISCAN for 3 dimensional contrast-enhanced magnetic resonance angiography (3D CE MRA) compared to 2 dimensional time-of-flight (2D TOF) MRA in the identification	—

Measure

Time frame

Primary end point(s): To determine the efficacy of 0.1 mmol/kg OMNISCAN for 3 dimensional contrast-enhanced magnetic resonance angiography (3D CE MRA) compared to 2 dimensional time-of-flight (2D TOF) MRA in the identification of the presence or absence of main haemodynamically relevant stenoses (ie, =50% or occlusion) within turbulent flow arteries of the aorto-iliac region. Intra-arterial digital subtraction angiography (IA DSA) will be used as the standard of truth. Co-primary endpoints The following primary efficacy endpoints will be evaluated simultaneously for each MRA reader: (1)Difference in sensitivity between 3D CE MRA and 2D TOF MRA in the identification of the main haemodynamically relevant stenosis (ie, =50% or occlusion) on a subject level across the 7 aorto iliac arterial segments with IA DSA as the standard of truth. The main stenosis is defined as the stenosis with the highest grade (ie, percentage decrease in vessel diameter) in one of the 7 vessel segments as determined by the IA DSA blinded image evaluation (BIE). (2)Difference in specificity between 3D CE MRA and 2D TOF MRA in the identification of a haemodynamically relevant stenosis (ie, =50% or occlusion) based on all of the 7 aorto-iliac arterial segments combined with IA DSA as the standard of truth. All vessel segments across all subjects which are determined to have no haemodynamically relevant stenosis by the IA DSA BIE will be considered for the calculation of specificity. The results of 3 independent blinded MRA readers in each subject will be compared separately to the IA DSA findings (read by 2 blinded DSA readers independently - in case of a mismatch between the 2 readers, the readers will be brought together, evaluate the images together and reach consensus). ;Main Objective: To determine the efficacy of 0.1 mmol/kg OMNISCAN for 3 dimensional contrast-enhanced magnetic resonance angiography (3D CE MRA) compared to 2 dimensional time-of-flight (2D TOF) MRA in the identification

—

Countries

Austria, Sweden

Outcome results

None listed

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