Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)

• Status: Unknown status
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AMAG Pharmaceuticals, Inc.
• Treatments: Ferrosoferric Oxide

Criteria

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