Efficacy evaluation of MRA images injected with a contrast product forpatient suffering from abdominal or lower limb arterial diseases:Comparison of 2 products DOTAREM® and GADOVIST®.
- Conditions
- Patient suffering from abdominal or lower limb arterial diseasesMedDRA version: 13.1Level: PTClassification code 10062585Term: Peripheral arterial occlusive diseaseSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2009-010968-42-DE
- Lead Sponsor
- GUERBET
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 188
- 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.
- Female of childbearing potential must have effective contraception (contraceptive pill or Intra-Uterine Device), or be surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea) or must have a documented negative urine or blood pregnancy test at screening
- Patient able to understand and who have provided written informed consent to participate in the trial.
- Patient with national health insurance
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 188
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 188
- 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).
- Patient with known severe adverse drug reaction or contraindication to one of the investigational products (Dotarem® or Gadovist®).
- 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 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 extra-anatomic bypass from axillar artery to the iliacs, iliaco-femoral bypass grafts, ipsilateral stents and ipsilateral knee and/or hip prosthesis.
- Patient having participated in any investigational drug study within 30 days prior the study enrolment.
- Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits (for example: mental or physical incapacity, language comprehension, geographical localisation, etc…).
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method