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
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Arterial Disease (PAD)
• Peripheral Vascular Diseases

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