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

• Conditions: Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III; MedDRA version: 9.1Level: LLTClassification code 10062585Term: Peripheral arterial occlusive disease; MedDRA version: 9.1Level: PTClassification code 10062585Term: Peripheral arterial occlusive disease

• Registration Number: EUCTR2009-011002-42-DE
• Lead Sponsor: GUERBET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-08
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified