Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III MedDRA version: 9.1 Level: LLT Classification code 10062585 Term: Peripheral arterial occlusive disease MedDRA version: 9.1 Level: PT Classification code 10062585 Term: Peripheral arterial occlusive disease
Conditions
Interventions
Trade Name: Gadovist, 1mmol/ml
Product Name: Gadovist 1mmol/ml, solution for injection, pre-filled syringe
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadobutrol
CAS Number: 13807
Sponsors
GUERBET
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female or male , aged = 18 years Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III. Female of childbearing potential must have effective contraception (contraceptive pill or Intra-Uterine Device), or be surgically sterilized, or post-menopausal (minimum 12months of amenorrhea) or must have a documented negative urine or blood pregnancy test at screening Patients having provided their written informed consent to participate in the trial Patients with national health insurance 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: Patient with a contraindication to MRI (e.g., pacemaker, aneurysm clip, severe claustrophobia, metallic joint replacement or others according to the imaging laboratory's standard practice). Patients with severely impaired renal function with a eGFR (MDRD) < 50ml/min (eGFR based on recent serum creatinine and MDRD formula - younger than 21 days). Patient with known severe adverse drug reaction or contraindication to one of the investigational products. Patient having received any contrast media within 48 hours prior to administration of investigational product for the enhanced-MRA. Patient planned to undergo therapeutic intervention in the vessels of interest between the two MRA procedure. Patient who had a major cardiovascular event within 30 days prior to the inclusion. Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits. Patient under guardianship and/or Inability or unwillingness to cooperate with the requirements of this trial. Pregnant or breast feeding patient. Patients already included in this trial Patients included in another clinical trial involving an Investigational Medicinal Product (IMP)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical equivalence of the diagnostic performance of DOTAREM®-enhanced MRA as compared to GADOVIST® - enhanced MRA by comparing the arterial visualization of vessels from the abdominal aorta to pedal artery.;Secondary Objective: The secondary objectives of the trial are: To compare DOTAREM®-enhanced MRA versus GADOVIST®-enhanced MRA in term of: - number of assessable segments - number of significant stenosis depicted, - image quality of the collateral circulation, - image quality of pedal vessel and smaller branches - diagnostic confidence - patient clinical management - venous overlap - duration of the procedure - signal intensity To compare the clinical tolerance of both contrast media during and up to 24 hours after each MRA examination. ;Primary end point(s): The primary criterion is the overall image quality of each MRA examination. Image quality will be assessed on a 5-point scale: (1) Excellent: allows delineation of the artery wall, visualization of the sub-segments and additional information other than arterial stenosis (e.g. accessory arteries, collateral circulation etc). (2) More than adequate: allows delineation of the artery wall and visualization of the sub-segments. (3) Adequate: allows the arteries and the sub-segments visualization (thus, allow the quantitative evaluation of a possible stenosis). (4) Less than adequate: allows potential stenosis visualization, but quantitative assessment is not possible along the entire main artery. (5) Non-diagnostic: does not allow the artery to be assessed in terms of presence or absence of stenosis. | — |
Countries
Germany
Outcome results
None listed