Subjects with moderate-to-severe peripheral arterial disease based on the Fontaine’s staging of peripheral arterial occlusive disease classes IIb, III and IV
Conditions
Interventions
Trade Name: MultiHance
Product Name: MULTIHANCE
Pharmaceutical Form: Solution for injection
Other descriptive name: GADOBENATE DIMEGLUMINE
Concentration unit: g gram(s)
Concentration number: 52,90-
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Sponsors
Bracco Imaging S.p.A.
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: • subjects scheduled to undergo intervention, surgical or otherwise, for the treatment of PAOD between the two MRA examinations • subjects scheduled to undergo DSA within the 24 hours pre or within the 24 hours post MRA exam 1 and 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective for this study is: •To compare MULTIHANCE and OMNISCAN 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;Secondary Objective: The secondary objectives for this study are: •To compare the two different investigational products, MULTIHANCE and OMNISCAN 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 compare the two different investigational products, MULTIHANCE and OMNISCAN at the same dose of 0.1 mmol/kg (0.2 ml/kg) using DSA as the standard of reference in terms of: •sensitivity and specificity in the detection of clinically relevant steno-occlusive disease (= 51%) of the peripheral arteries •detection of collateral circulation •detection of aneurysm •To assess the inter-reader agreement in terms of: •sensitivity and specificity in the detection of clinically relevant steno-occlusive disease (= 51%) of the peripheral arteries •average quality of visualization ;Primary end point(s): comparing images acquired with MultiHance and images acquired with Omniscan will be determined the Global diagnostic preference (primary endpoint) obtained in a paired global assessment | — |
Countries
Austria
Outcome results
None listed