Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

Guerbet

Status and phase: Completed; Phase 3

Conditions: Cerebral Arterial Diseases

Treatments: Other: TOF MRA; Drug: Dotarem

Study type: Interventional

Funder types: Industry

Identifiers

NCT01010932

DGD-44-048

Details and patient eligibility

About

The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.

Full description

Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, aged more than 18 years
• Strongly suspected of having carotid or vertebral arterial disease
• Scheduled (or to be scheduled) to undergo computed tomography angiography (CTA) examination

Exclusion criteria

• Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²)
• Contraindication to MRI
• Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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222 participants in 1 patient group

Dotarem and TOF MRA

Experimental group

Description:

Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.

Treatment:

Drug: Dotarem

Other: TOF MRA