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NCT00707876 Clinical Trial

Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)

Peripheral Arterial Disease (PAD) Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00707876
Other study ID # FER-PAD-001
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date September 2008
Est. completion date August 2019

Study information
Verified date April 2019
Source AMAG Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 108
Est. completion date August 2019
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ferumoxytol
Dose 1 versus non-contrast MRA
• ferumoxytol
Dose 2 versus non-contrast MRA
• ferumoxytol
Dose 3 versus non-contrast MRA

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AMAG Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess sensitivity and specificity of non-contrast MRA and VE-MRI at three ferumoxytol dosing levels 3 weeks
Secondary To assess positive and negative predictive values of VE-MRI using ferumoxytol at different dosing levels. 3 weeks
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