Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)

AMAG Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Peripheral Arterial Disease (PAD)

Treatments: Drug: ferumoxytol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00707876

FER-PAD-001

Details and patient eligibility

About

The purpose of this study is to compare the difference between two magnetic resonance imaging (MRI) techniques for visualizing arteries. The study hypothesizes that one method that relies upon imaging flowing blood in the pelvic and leg arteries will not be as accurate or efficient as injecting a safe imaging agent to change the appearance of the blood on the MRI. Both methods will be compared with Digital Subtraction Angiography (DSA).

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with symptoms of PAD
• Scheduled for DSA

Exclusion criteria

• Critical leg ischemia manifested by ulcers, gangrene or leg amputation
• Laboratory evidence of iron overload, liver disease, pregnancy
• History of allergy to or recent exposure to radiocontrast, gadolinium chelates, or intravenous iron therapy
• Clinical concerns about co-morbidities, subject suitability

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

1

Experimental group

Description:

Dose 1 versus non-contrast MRA

Treatment:

Drug: ferumoxytol

Drug: ferumoxytol

Drug: ferumoxytol

2

Experimental group

Description:

Dose 2 versus non-contrast MRA

Treatment:

Drug: ferumoxytol

Drug: ferumoxytol

Drug: ferumoxytol

3

Experimental group

Description:

Dose 3 versus non-contrast MRA

Treatment:

Drug: ferumoxytol

Drug: ferumoxytol

Drug: ferumoxytol