Peripheral Arterial Disease
Conditions
Keywords
MRA-Contrast agent comparison in peripheral disease
Brief summary
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.
Interventions
Sponsors
Guerbet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, aged ≥ 18 years. * Patient with infrarenal aorta or chronic lower limb ischemia with various clinical signs of gravity (stages II-IV according to the classification of Leriche and Fontaine) or/and Doppler ultrasonography indicating abdominal or lower limb arteriopathy. * Patient scheduled for a conventional X-Ray angiography (intra-arterial Digital Substraction Angiography = DSA) within 30 days of MRA with a minimum time interval of at least 24 hours between the 2 examinations.
Exclusion criteria
* Patient planned to undergo therapeutic intervention in abdominal or lower limb vessels between the time of MRA and X-ray Angiography will be performed. * Patient who had a major cardiovascular event within 30 days prior to the inclusion. * Patient treated with unilateral hip replacement, abdominal aortic or iliac graft or stent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-patient Accuracy (Percent Agreement), On-site Data | up to one month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-patient Accuracy, in Off-site Readings | up to one month | • 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 |
| Specificity | up to one month | 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). |
| Sensitivity | up to one month | 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). |
Countries
Austria
Participant flow
Recruitment details
Recruitment period between october 2009 and January 2011. Patients were recruited in hospitals.
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| Gadovist Patient received contrast-enhanced MRA with Gadovist | 93 |
| Dotarem, Interventional Patients received contrast-enhanced MRA with Dotarem | 93 |
| Total | 186 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | change of treatment, patient moved | 4 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Gadovist | Dotarem, Interventional | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 45 Participants | 45 Participants | 90 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 48 Participants | 96 Participants |
| Age Continuous | 66.5 years STANDARD_DEVIATION 10.2 | 66.8 years STANDARD_DEVIATION 10.6 | 66.7 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment Austria | 19 participants | 18 participants | 37 participants |
| Region of Enrollment France | 16 participants | 20 participants | 36 participants |
| Region of Enrollment Germany | 7 participants | 7 participants | 14 participants |
| Region of Enrollment Italy | 16 participants | 16 participants | 32 participants |
| Region of Enrollment Spain | 35 participants | 32 participants | 67 participants |
| Sex: Female, Male Female | 21 Participants | 18 Participants | 39 Participants |
| Sex: Female, Male Male | 72 Participants | 75 Participants | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 92 | 2 / 92 |
| serious Total, serious adverse events | 0 / 93 | 1 / 93 |
Outcome results
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.
Time frame: up to one month
Population: Per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadovist | Intra-patient Accuracy (Percent Agreement), On-site Data | 77.1 percentage of agreement | Standard Deviation 19.6 |
| Dotarem, Interventional | Intra-patient Accuracy (Percent Agreement), On-site Data | 80.6 percentage of agreement | Standard Deviation 16.1 |
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
Time frame: up to one month
Population: Ecah images from each patient were analysed by two external readers, this means that each patient was analyzed twice.~Per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadovist | Intra-patient Accuracy, in Off-site Readings | 75.1 percentage of agreement | Standard Deviation 15.3 |
| Dotarem, Interventional | Intra-patient Accuracy, in Off-site Readings | 73.9 percentage of agreement | Standard Deviation 16.7 |
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).
Time frame: up to one month
Population: Per protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadovist | Sensitivity | 168 positive segment with MRA |
| Dotarem, Interventional | Sensitivity | 191 positive segment with MRA |
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).
Time frame: up to one month
Population: per protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadovist | Specificity | 756 negative segments in MRA |
| Dotarem, Interventional | Specificity | 763 negative segments in MRA |