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

Guerbet

Status and phase

Completed

Phase 4

Conditions

Peripheral Arterial Disease

Treatments

Drug: Dotarem

Drug: Gadovist

Study type

Interventional

Funder types

Industry

Identifiers

NCT01026389

DGD 44-045

Details and patient eligibility

About

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.

Enrollment

189 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.