Renal artery stenosis (RAS) is implicated as the underlying cause in 1% to 5% of patients with hypertension and 5% to 15% of patients with end-stage renal disease entering dialysis programs each year. Several endovascular procedures are now available for treatment. The introduction of such procedures has considerably increased the need not only for accurate detection but also for precise anatomic mapping of the extent and severity of an existing lesion.
Conditions
Interventions
Trade Name: Omniscan
Product Name: Omniscan
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: GADODIAMIDE
Concentration unit: mmol/ml millimole(s)/millilitre
Concentration type: equal
Con
Sponsors
Amersham plc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The subject has a suspicion of or known renal artery stenosis. (2) The subject has been referred to IA-DSA. (3) The subject has had no intervention or a change in symptoms between 3D CE-MRA and IA-DSA. (4) The subject is 18 years or older. (5) The subject is conscious and able to comply with study procedures. (6) Written and dated (i.e. date and time) informed consent is obtained. (7) For women of childbearing potential, the results of a serum or urine human chorionic gonadotropin (â-HCG) pregnancy test, done at screening (with the result known before investigational product administration), must be negative. Only those women, who are surgically sterile (have had a documented bilateral oophorectomy and/or documented hysterectomy) or postmenopausal (cessation of menstruation for >1 year) will be allowed to enrol in the study without a pregnancy test at screening. 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: (1) The subject has a known hypersensitivity to either conventional X-ray or gadolinium-based MR contrast media including, but not restricted to, the investigational product. (2) The subject is lactating. (3) The subject is pregnant as defined by a serum or urine â-HCG pregnancy test obtained within 24 hours before investigational product administration. (4) The subject has received or is scheduled to receive MRI contrast medium within 24 h prior to or less than 24 hours after the investigational product administration. (5) The subject has received or is scheduled to receive X-ray contrast medium within less than 24 hours prior to or less than 24 hours after administration of investigational product. (6) The subject has received an investigational product within 30 days prior to or will receive an investigational product less than 24 hours after investigational product administration. (7) The subject has an active, serious, life-threatening disease with a life expectancy of less than 6 months. (8) The subject has had a percutaneous transluminal angioplasty (PTA) in the renal region performed within 4 weeks prior to investigational product administration. (9) The subject has a stent in the renal arteries. (10) The subject has had a kidney transplantation. (11) The subject has a serum creatinine value of >3.5 mg/dL (309.4 µmol/L). (12) The subject has previously been included in this study. (13) The subject has a contra-indication for MRI according to accepted clinical guidelines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy of 0.1 mmol/kg OMNISCAN for three-dimensional (3D) contrast enhanced (CE)-MRA in determining the presence or absence of a haemodynamically relevant stenosis (i.e., =50% or occlusion) on a subject level across both major renal arteries. Intra-arterial Digital Subtraction Angiography (IA-DSA) will be used as the standard of truth.;Secondary Objective: To assess the efficacy and the influence on making a diagnosis of 3D CE- and 2D TOF-MRA in regions predisposed to turbulent flow. To determine the efficacy of 2D TOF-MRA in determining the presence or absence of haemodynamically relevant (HR) stenosis on a subject level across both major renal arteries. To assess the efficacy of 3D CE-MRA and 2D TOF-MRA in determining the presence or absence of HR stenoses on a vessel level To assess the efficacy of 3D CE-MRA and 2D TOF-MRA in the combined determination of the presence of absence of HR stenoses in major renal arteries. To evaluate the impact of 3D CE-MRA findings compared to those of IA-DSA and 2D TOF-MRA. To compare 3D CE-MRA with 2D TOF-MRA in the detection of accessory renal arteries. To describe image quality and number of segments evaluable in the renal region for each modality. To confirm the safety of 0.1 mmol/kg OMNISCAN in renal MRA. To confirm the safety of OMNISCAN administration via power injector.;Primary end point(s): The primary endpoint of this study is the sensitivity and specificity of 3D CE-MRA in detecting the main haemodynamically relevant stenosis (i.e., =50% or occlusion) on a subject level across both major renal arteries (“subject’s main stenosis/occlusion”). IA-DSA will be used as the standard of truth. The results of 3 independent blinded MRA readers assessing the main stenosis in each subject (based on BIE) will be compared separately to the IA-DSA findings. | — |
Countries
Lithuania
Outcome results
None listed