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A PHASE IIIB, DOUBLE-BLIND, MULTI-CENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE 0.1 MMOL/KG OF MULTIHANCE® WITH 0.1 MMOL/KG OF MAGNEVIST® FOR CONTRAST-ENHANCED MAGNETIC RESONANCE ANGIOGRAPHY (CE-MRA) OF PERIPHERAL ARTERIES - STEP

A PHASE IIIB, DOUBLE-BLIND, MULTI-CENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE 0.1 MMOL/KG OF MULTIHANCE® WITH 0.1 MMOL/KG OF MAGNEVIST® FOR CONTRAST-ENHANCED MAGNETIC RESONANCE ANGIOGRAPHY (CE-MRA) OF PERIPHERAL ARTERIES - STEP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-002274-22-DE
Enrollment
100
Registered
2006-07-27
Start date
2006-12-18
Completion date
Unknown
Last updated
2013-05-06

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

Conditions

Subjects with moderate-to-severe peripheral arterial disease based on the Fontaine’s staging of peripheral arterial occlusive disease classes IIb, III and IV MedDRA version: 8.1 Level: LLT Classification code 10062585 Term: Peripheral arterial occlusive disease

Interventions

Trade Name: MultiHance Product Name: MULTIHANCE Pharmaceutical Form: Solution for injection CAS Number: 113662-23-0 Other descriptive name: GADOBENATE DIMEGLUMINE Concentration unit: g/l gram(s)/litre

Sponsors

Bracco Imaging S.p.A.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: subjects wiìth moderate-to-severe peripheral arterial disease based on the Fontaine’s staging of peripheral arterial occlusive disease classes IIb, III and IV 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: •Has moderate to severe renal impairment (defined as GFR/eGFR, < 60 mL/min) •Has had therapeutic intervention of any kind for vascular disease in the arterial territory of interest performed between the two MRA procedures •Has changed in clinical symptoms related to vascular disease between the two MRA procedures

Design outcomes

Primary

MeasureTime frame
Secondary Objective: The secondary objectives for this study are: •To compare the two different investigational products, MULTIHANCE and MAGNEVIST at the same dose of 0.1 mmol/kg (0.2 ml/kg) in terms of: •signal intensity enhancement at station level •average quality of visualization •technical failure rate •To assess the inter-reader agreement in terms of: •average quality of visualization ;Primary end point(s): comparing images acquired with MultiHance and images acquired with MAGNEVIST will be determined the Global diagnostic preference (primary endpoint) obtained in a paired global assessment;Main Objective: The primary objective for this study is: • To compare MULTIHANCE and MAGNEVIST at the same dose of 0.1 mmol/kg (0.2 ml/kg), in terms of global paired diagnostic preference in the assessment of peripheral steno-occlusive disease—

Countries

Austria, Germany

Outcome results

None listed

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