Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)

AMAG Pharmaceuticals, Inc.108 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

108

Conditions

Peripheral Arterial Disease (PAD)

Interventions

ferumoxytolDRUG

Dose 1 versus non-contrast MRA

ferumoxytolDRUG

Dose 2 versus non-contrast MRA

ferumoxytolDRUG

Dose 3 versus non-contrast MRA

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Lexington, Massachusetts, United States

Outcomes

Primary Outcomes

To assess sensitivity and specificity of non-contrast MRA and VE-MRI at three ferumoxytol dosing levels

Time frame: 3 weeks

Secondary Outcomes

To assess positive and negative predictive values of VE-MRI using ferumoxytol at different dosing levels.

Time frame: 3 weeks

Data from ClinicalTrials.gov

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