CompletedPhase 2

Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)

United States119 participantsStarted 2008-09-01

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Segment-level Sensitivity and Specificity of VE-MRI at 3 Ferumoxytol Dosing Levels and Differences in Sensitivity and Specificity by Dose Group

Timeframe: 3 weeks

Segment-level Sensitivity and Specificity of Noncontrast MRA at 3 Ferumoxytol Dosing Levels and Difference From Sensitivity by Dose Group

Timeframe: 3 weeks

Trial details

NCT IDNCT00707876

SponsorAMAG Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-07-02

Results submitted2023-08-08

View on ClinicalTrials.gov More Peripheral Arterial Disease (PAD) trials