DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in Patients With Abdominal or Lower Limb Arterial Diseases

Guerbet

Status and phase: Completed; Phase 4

Conditions: Peripheral Arterial Disease

Treatments: Other: Contrast-enhanced MRA - Imaging examination

Study type: Interventional

Funder types: Industry

Identifiers

NCT00955617

DGD-44-052

Details and patient eligibility

About

This study is an intra-individual comparison of DOTAREM®-enhanced MRA and GADOVIST®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female or male, aged ≥ 18 years
• Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III.

Exclusion criteria

• Patients with severely impaired renal function with an eGFR (MDRD) < 50ml/min (eGFR based on recent serum creatinine and MDRD formula - younger than 21 days).
• Patient planned to undergo therapeutic intervention in the vessels of interest between the two MRA procedures.
• Patient who had a major cardiovascular event within 30 days prior to the inclusion.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Dotarem / Gadovist

Experimental group

Description:

Contrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Dotarem in period 1 then with Gadovist in period 2

Treatment:

Other: Contrast-enhanced MRA - Imaging examination

Gadovist / Dotarem

Experimental group

Description:

Contrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Gadovist in period 1 then with Dotarem in period 2

Treatment:

Other: Contrast-enhanced MRA - Imaging examination