Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)

NCT ID: NCT00707876

Last Updated: 2019-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2019-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Peripheral Arterial Disease (PAD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Dose 1 versus non-contrast MRA

Group Type EXPERIMENTAL

ferumoxytol

Intervention Type DRUG

Dose 1 versus non-contrast MRA

2

Dose 2 versus non-contrast MRA

Group Type EXPERIMENTAL

ferumoxytol

Intervention Type DRUG

Dose 2 versus non-contrast MRA

3

Dose 3 versus non-contrast MRA

Group Type EXPERIMENTAL

ferumoxytol

Intervention Type DRUG

Dose 3 versus non-contrast MRA

Interventions

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ferumoxytol

Dose 1 versus non-contrast MRA

Intervention Type DRUG

ferumoxytol

Dose 2 versus non-contrast MRA

Intervention Type DRUG

ferumoxytol

Dose 3 versus non-contrast MRA

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AMAG Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Strauss, MD

Role: STUDY_DIRECTOR

AMAG Pharmaceuticals, Inc.

Locations

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Lexington, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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FER-PAD-001

Identifier Type: -

Identifier Source: org_study_id

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