Phase II, Open Label, Randomized, Multicenter Trial Comparing Noncontrast MRA vs. Ferumoxytol Vascular Enhanced MRI for Detection of Stenosis or Occlusion of the Aortoiliac and Superficial Femoral Arteries in PAD Subjects Scheduled for DSA
Phase II, Open Label, Randomized, Multicenter Trial Comparing Noncontrast MRA vs. Ferumoxytol Vascular Enhanced MRI for Detection of Stenosis or Occlusion of the Aortoiliac and Superficial Femoral Arteries in PAD Subjects Scheduled for DSA
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).
This was a Phase 2, open-label, randomized, multicenter study to evaluate the efficacy and safety of a single administration of intravenous (IV) ferumoxytol at 3 dose levels as a VE-MRI imaging agent to facilitate detection of arterial stenosis in subjects with PAD. Eligible subjects were already scheduled for DSA to be completed within 14 days of the MR assessments. Nineteen sites randomized subjects in the study. The sites were selected such that an equal number of subjects could be scanned on the 3 major MRI 1.5 T platforms (Siemens, General Electric, and Philips).
Subjects were stratified by imaging platform and randomized to receive 1.0, 2.5, or 4.0 mg/kg IV ferumoxytol. On the same study day, subjects first underwent a noncontrast MRA, followed by administration of the randomized ferumoxytol dose and VE-MRI. Within 2 weeks subjects then underwent the previously scheduled DSA of the aortoiliac and superficial femoral arteries that served as the reference "gold standard."
Inclusion Criteria:
Exclusion Criteria: