Phase 2
N=119
Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)
Peripheral Arterial Disease (PAD)
Bottom Line
View on ClinicalTrials.gov: NCT00707876 ↗Enrolled (actual)
119
Serious AEs
9.2%
Results posted
Apr 2026
Primary outcome: Primary: Segment-level Sensitivity and Specificity of VE-MRI at 3 Ferumoxytol Dosing Levels and Differences in Sensitivity and Specificity by Dose Group — 71.8; 76.8; 81.8; 71.2 percent agreement
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ferumoxytol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AMAG Pharmaceuticals, Inc.
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Segment-level Sensitivity and Specificity of VE-MRI at 3 Ferumoxytol Dosing Levels and Differences in Sensitivity and Specificity by Dose Group |
71.8; 76.8; 81.8; 71.2; 76.5; 75.2 | — |
| PRIMARY Segment-level Sensitivity and Specificity of Noncontrast MRA at 3 Ferumoxytol Dosing Levels and Difference From Sensitivity by Dose Group |
49.3; 53.6; 50.0; 54.1; 46.3; 54.6 | — |
| SECONDARY Segment-level Positive and Negative Predictive Values of VE-MRI Using Ferumoxytol at 3 Dosing Levels |
54.8; 60.2; 60.7; 83.9; 87.7; 89.8 | — |
| SECONDARY Segment-level Positive and Negative Predictive Values of Noncontrast MRA |
34.3; 31.6; 34.0; 68.7; 68.3; 70.0 | — |
| SECONDARY Segment-level Total Percent, Positive Percent Between VE-MRI and Noncontrast MRA |
46.5; 46.4; 45.5; 47.9; 53.6; 48.5 | — |
| SECONDARY Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers |
74.2; 69.2; 78.3; 58.7; 69.6; 70.0 | — |
| SECONDARY Segment-level Negative Percent Agreements VE-MRI and Noncontrast MRA |
25.4; 15.9; 13.6; 9.9; 13.0; 22.7 | — |
| SECONDARY Segment-level Total Percent, Kappa Statistics Between VE-MRI and Noncontrast MRA |
0.440; 0.216; 0.182; 0.027; 0.256; 0.401 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00707876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.