Overview

This trial is active, not recruiting.

Condition peripheral arterial disease (pad)
Treatments ferumoxytol
Phase phase 2
Sponsor AMAG Pharmaceuticals, Inc.
Start date September 2008
End date July 2010
Trial size 108 participants
Trial identifier NCT00707876, FER-PAD-001

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Dose 1 versus non-contrast MRA
ferumoxytol
Dose 1 versus non-contrast MRA
(Experimental)
Dose 2 versus non-contrast MRA
ferumoxytol
Dose 2 versus non-contrast MRA
(Experimental)
Dose 3 versus non-contrast MRA
ferumoxytol
Dose 3 versus non-contrast MRA

Primary Outcomes

Measure
To assess sensitivity and specificity of non-contrast MRA and VE-MRI at three ferumoxytol dosing levels
time frame:

Secondary Outcomes

Measure
To assess positive and negative predictive values of VE-MRI using ferumoxytol at different dosing levels.
time frame:

Eligibility Criteria

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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by AMAG Pharmaceuticals, Inc..