Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)

NCT00707876 | Completed Phase 2 Results

• 1 other identifier: FER-PAD-001
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Peripheral Arterial Disease (PAD)

Keywords

Peripheral arterial disease (PAD); Magnetic Resonance Angiography (MRA); Magnetic Resonance Imaging (MRI); imaging agent or biomarker

Outcome Measures

Primary Outcomes (2)

• Segment-level Sensitivity and Specificity of VE-MRI at 3 Ferumoxytol Dosing Levels and Differences in Sensitivity and Specificity by Dose Group

  Analysis of the sensitivity and specificity of VE-MRI by dose group was performed on the ITD segments by 3 Readers. The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms.

  3 weeks

• Segment-level Sensitivity and Specificity of Noncontrast MRA at 3 Ferumoxytol Dosing Levels and Difference From Sensitivity by Dose Group

  Analysis of the sensitivity and specificity of noncontrast MRA by dose group was performed on the ITD segments by 3 Readers. The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. The data were pooled across all imaging platforms.

  3 weeks

Secondary Outcomes (6)

• Segment-level Positive and Negative Predictive Values of VE-MRI Using Ferumoxytol at 3 Dosing Levels

  3 weeks

• Segment-level Positive and Negative Predictive Values of Noncontrast MRA

  3 weeks

• Segment-level Total Percent, Positive Percent Between VE-MRI and Noncontrast MRA

  3 weeks

• Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers

  3 weeks

• Segment-level Negative Percent Agreements VE-MRI and Noncontrast MRA

  3 weeks

Study Arms (3)

Cohort 1

EXPERIMENTAL

1.0 mg/kg IV ferumoxytol versus non-contrast MRA

Drug: ferumoxytol

Cohort 2

EXPERIMENTAL

2.5 mg/kg IV ferumoxytol versus non-contrast MRA

Drug: ferumoxytol

Cohort 3

EXPERIMENTAL

4.0 mg/kg IV ferumoxytol versus non-contrast MRA

Drug: ferumoxytol

Interventions

ferumoxytol DRUG

1.0 mg/kg IV ferumoxytol

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with symptoms of PAD
• Scheduled for DSA

You may not qualify if:

• 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

Sponsors & Collaborators

• AMAG Pharmaceuticals, Inc.: lead

Study Sites (1)

Unknown Facility

Lexington, Massachusetts, 02421, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Results Point of Contact

• Title: Clinical Trial Interest
• Organization: Covis Pharma

CTInterest@covispharma.com

1-877-374-4177

Study Officials

• William Strauss, MD

  AMAG Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 1, 2008
• Study Start: September 1, 2008
• Primary Completion: July 2, 2010
• Study Completion: August 15, 2020
• Last Updated: April 16, 2026
• Results First Posted: April 16, 2026

Record last verified: 2025-09

Locations

US (1)