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.