Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)
This trial is active, not recruiting.
|Condition||peripheral arterial disease (pad)|
|Sponsor||AMAG Pharmaceuticals, Inc.|
|Start date||September 2008|
|End date||July 2010|
|Trial size||108 participants|
|Trial identifier||NCT00707876, FER-PAD-001|
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).
|Endpoint classification||efficacy study|
|Intervention model||factorial assignment|
To assess sensitivity and specificity of non-contrast MRA and VE-MRI at three ferumoxytol dosing levels
To assess positive and negative predictive values of VE-MRI using ferumoxytol at different dosing levels.
Male or female participants at least 18 years old.
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
|Official title||A Phase II, Open Label, Randomized, Multicenter Trial Comparing Noncontrast MRA Versus Ferumoxytol Vascular Enhanced MRI (VE-MRI) for the Detection of Clinically Significant Stenosis or Occlusion of the Aortoiliac and Superficial Femoral Arteries in Subjects With Peripheral Arterial Disease Scheduled for Digital Subtraction Angiography (DSA)|
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