Overview

Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease

Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
0
Participant gender:
All
Summary
This study is an efficacy evaluation of Dotarem®-enhanced magnetic resonance angiography (MRA) compared to Gadovist®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Guerbet
Treatments:
Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.