Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)

April 25, 2019 updated by: AMAG Pharmaceuticals, Inc.

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)

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Lexington, Massachusetts, United States, 02421

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Dose 1 versus non-contrast MRA
Drug: ferumoxytol
Dose 1 versus non-contrast MRA
Drug: ferumoxytol
Dose 2 versus non-contrast MRA
Drug: ferumoxytol
Dose 3 versus non-contrast MRA
EXPERIMENTAL: 2
Dose 2 versus non-contrast MRA
Drug: ferumoxytol
Dose 1 versus non-contrast MRA
Drug: ferumoxytol
Dose 2 versus non-contrast MRA
Drug: ferumoxytol
Dose 3 versus non-contrast MRA
EXPERIMENTAL: 3
Dose 3 versus non-contrast MRA
Drug: ferumoxytol
Dose 1 versus non-contrast MRA
Drug: ferumoxytol
Dose 2 versus non-contrast MRA
Drug: ferumoxytol
Dose 3 versus non-contrast MRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess sensitivity and specificity of non-contrast MRA and VE-MRI at three ferumoxytol dosing levels
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess positive and negative predictive values of VE-MRI using ferumoxytol at different dosing levels.
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AMAG Pharmaceuticals, Inc.

Investigators

  • Study Director: William Strauss, MD, AMAG Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ANTICIPATED)

August 1, 2019

Study Registration Dates

First Submitted

June 27, 2008

First Submitted That Met QC Criteria

June 30, 2008

First Posted (ESTIMATE)

July 1, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FER-PAD-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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