Renal Artery Stenosis
Conditions
Keywords
Renal artery stenosis, Contrast agent, MRA
Brief summary
The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.
Detailed description
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.
Interventions
Each subject will receive one injection of Dotarem 0.2 ml/kg
OTHERTime of Flight Magnetic Resonance Angiography
Each subject will undergo a TOF MRA
Sponsors
Guerbet
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, aged more than 18 years, * Strongly suspected of having renal arterial disease, * Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination,
Exclusion criteria
* Known grade IV or V chronic kidney disease (GFR\<30 mL/min/1.73m²), * Contraindication to MRI, * Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Non Assessable Renal Artery Segments | 1 to 7 days | For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared |
Countries
United States
Participant flow
Recruitment details
First Patient First Visit: Apr 2009 Last Patient Last Visit: Feb 2010 Location: Radiology centers
Pre-assignment details
Out of the 33 enrolled patients, one patient did not undergo any of the planned procedures due to an inability to obtain an intravenous access with the initial planned procedure.
Participants by arm
| Arm | Count |
|---|---|
| TOF and Dotarem Enhanced MRA Each subject will undergo a Time of Flight Magnetic Resonance Angiography followed by a Dotarem-enhanced Magnetic Resonance Angiography (with injection of Dotarem 0.2 ml/kg). | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | TOF and Dotarem Enhanced MRA |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 62 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 32 | 0 / 32 |
| serious Total, serious adverse events | 1 / 32 | 0 / 32 |
Outcome results
Primary
Percent of Non Assessable Renal Artery Segments
For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared
Time frame: 1 to 7 days
Population: The study has been prematurely terminated, and the planned analyses were not done