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This study is an efficacy evaluation of Dotarem®-enhanced magnetic resonance angiography (MRA) compared to Gadovist®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gadovist | Active Comparator | Patient received contrast-enhanced MRA with Gadovist |
|
| Dotarem, interventional | Experimental | Patients received contrast-enhanced MRA with Dotarem |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dotarem | Drug | DOTAREM, 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intra-patient Accuracy (Percent Agreement), On-site Data | intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography. | up to one month |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-patient Accuracy, in Off-site Readings | • Intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography, in off-site readings, using the same methodology as that used for the primary criterion | up to one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKH hospital | Vienna | Austria |
3 patients were not randomized: 2 patients because of technical issue and one patient because of sponsor decision (inclusion period finished/ number of evaluable patients achieved)
Recruitment period between october 2009 and January 2011. Patients were recruited in hospitals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gadovist | Patient received contrast-enhanced MRA with Gadovist |
| FG001 | Dotarem | Patients received contrast-enhanced MRA with Dotarem |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gadovist | Patient received contrast-enhanced MRA with Gadovist |
| BG001 | Dotarem, Interventional | Patients received contrast-enhanced MRA with Dotarem |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intra-patient Accuracy (Percent Agreement), On-site Data | intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography. | Per protocol population | Posted | Mean | Standard Deviation | percentage of agreement | up to one month |
|
15 months in total For each patient, adverse events were collected from signature of inform consent form to the end of the DSA
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gadovist | Patient received contrast-enhanced MRA with Gadovist |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA (10.0) | Systematic Assessment | Not related, occured prior to administration of study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Folliculis | Infections and infestations | MedDRA (10.0) | Systematic Assessment | Not related, mild |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Post M. A. Clinical Unit Manager | Guerbet | +33 1 45 91 50 00 | corinne.dubourdieu@guerbet-group.com |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C072417 | gadoterate meglumine |
| C050823 | gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate |
| C090600 | gadobutrol |
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| Gadovist | Drug | Gadovist, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus |
|
|
| Specificity | Specificity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site readings; no stenosis and non significant stenosis were grouped as one class (non significant stenosis = negative segment). | up to one month |
| Sensitivity | sensitivity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site; moderate, severe stenosis and occlusion were grouped as one class (significant stenosis = positive segment). | up to one month |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Intra-patient Accuracy, in Off-site Readings | • Intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography, in off-site readings, using the same methodology as that used for the primary criterion | Ecah images from each patient were analysed by two external readers, this means that each patient was analyzed twice. Per protocol population | Posted | Mean | Standard Deviation | percentage of agreement | up to one month | images | Participants |
|
|
|
| Secondary | Specificity | Specificity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site readings; no stenosis and non significant stenosis were grouped as one class (non significant stenosis = negative segment). | per protocol population | Posted | Number | negative segments in MRA | up to one month | Negative segment with gold standard | Participants |
|
|
|
| Secondary | Sensitivity | sensitivity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site; moderate, severe stenosis and occlusion were grouped as one class (significant stenosis = positive segment). | Per protocol population | Posted | Number | positive segment with MRA | up to one month | positive segment with gold standard | Participants |
|
|
|
| 0 |
| 93 |
| 2 |
| 92 |
| EG001 | Dotarem, Interventional | Patients received contrast-enhanced MRA with Dotarem | 1 | 93 | 2 | 92 |
|
| carotid stenosis | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | Not related, occured prior to administration of study treatment |
|
|
| contrast extravasation | General disorders | MedDRA (10.0) | Systematic Assessment | Not related, mild |
|
| burning | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | Possibly related, mild |
|
| heat sensation in the face | Vascular disorders | MedDRA (10.0) | Systematic Assessment | Possibly related, mild |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |