Efficacy evaluation of DOTAREM®-enhanced MRA compared to GADOVIST®–enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases

Phase 1

• Conditions: Patient suffering from abdominal or lower limb arterial diseases; MedDRA version: 9.1Level: LLTClassification code 10062585Term: Peripheral arterial occlusive disease; MedDRA version: 9.1Level: PTClassification code 10062585Term: Peripheral arterial occlusive disease

• Registration Number: EUCTR2009-010968-42-ES
• Lead Sponsor: GUERBET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-06
• Study Completion: 2012-01-07
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

Male or female, aged = 18 years
Patient with 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 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:
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

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 unilateral hip replacement, abdominal aortic or iliac graft or stent.
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.
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