Peripheral Arterial Disease (PAD)Phase 2NCT00707876

Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)

A Phase 2 study testing ferumoxytol in people with Peripheral Arterial Disease (PAD), run by AMAG Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Arterial Disease (PAD)
What is being tested?: ferumoxytol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2008to 15 Aug 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with symptoms of PAD
Scheduled for DSA

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Lexington, Massachusetts, 02421

Other trials in United States

About this study

Official title: Phase II, Open Label, Randomized, Multicenter Trial Comparing Noncontrast MRA vs. Ferumoxytol Vascular Enhanced MRI for Detection of Stenosis or Occlusion of the Aortoiliac and Superficial Femoral Arteries in PAD Subjects Scheduled for DSA

Read the detailed description

This was a Phase 2, open-label, randomized, multicenter study to evaluate the efficacy and safety of a single administration of intravenous (IV) ferumoxytol at 3 dose levels as a VE-MRI imaging agent to facilitate detection of arterial stenosis in subjects with PAD. Eligible subjects were already scheduled for DSA to be completed within 14 days of the MR assessments. Nineteen sites randomized subjects in the study. The sites were selected such that an equal number of subjects could be scanned on the 3 major MRI 1.5 T platforms (Siemens, General Electric, and Philips).

Subjects were stratified by imaging platform and randomized to receive 1.0, 2.5, or 4.0 mg/kg IV ferumoxytol. On the same study day, subjects first underwent a noncontrast MRA, followed by administration of the randomized ferumoxytol dose and VE-MRI. Within 2 weeks subjects then underwent the previously scheduled DSA of the aortoiliac and superficial femoral arteries that served as the reference "gold standard."

Conditions: Peripheral Arterial Disease (PAD)
Being tested: ferumoxytol
Keywords: Peripheral arterial disease (PAD), Magnetic Resonance Angiography (MRA), Magnetic Resonance Imaging (MRI), imaging agent or biomarker
Medical subject headings: Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ferumoxytolDrug
1.0 mg/kg IV ferumoxytol
ferumoxytolDrug
2.5 mg/kg IV ferumoxytol
ferumoxytolDrug
4.0 mg/kg IV ferumoxytol

Study groups in NCT00707876
Study group	Role	What they receive
Cohort 1	Experimental	1.0 mg/kg IV ferumoxytol versus non-contrast MRA Receives: Drug: ferumoxytol
Cohort 2	Experimental	2.5 mg/kg IV ferumoxytol versus non-contrast MRA Receives: Drug: ferumoxytol
Cohort 3	Experimental	4.0 mg/kg IV ferumoxytol versus non-contrast MRA Receives: Drug: ferumoxytol

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 3 weeks

Secondary outcomes (6)

Segment-level Positive and Negative Predictive Values of VE-MRI Using Ferumoxytol at 3 Dosing Levels
The sensitivity and specificity estimated by imaging platforms and dose group by imaging platforms will be reported and statistical tests of whether sensitivity/specificity differs by imaging platforms will be done. 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.
Measured: 3 weeks
Segment-level Positive and Negative Predictive Values of Noncontrast MRA
The sensitivity and specificity estimated by imaging platforms and dose group by imaging platforms will be reported and statistical tests of whether sensitivity/specificity differs by imaging platforms will be done. 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.
Measured: 3 weeks
Segment-level Total Percent, Positive Percent Between VE-MRI and Noncontrast MRA
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.
Measured: 3 weeks
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent 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.
Measured: 3 weeks
Segment-level Negative Percent Agreements VE-MRI and Noncontrast MRA
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.
Measured: 3 weeks
Segment-level Total Percent, Kappa Statistics Between VE-MRI and Noncontrast MRA
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.
Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 200815 Aug 2020

First posted1 Jul 2008 (estimated)
Study start1 Sep 2008
Primary completion2 Jul 2010
Study completion15 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peripheral Arterial Disease (PAD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00707876
Sponsor's protocol ID: FER-PAD-001
Status last verified: Sep 2025
First submitted: 27 Jun 2008
Last updated: 16 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

All Peripheral Arterial Disease (PAD) trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II, Open Label, Randomized, Multicenter Trial Comparing Noncontrast MRA vs. Ferumoxytol Vascular Enhanced MRI for Detection of Stenosis or Occlusion of the Aortoiliac and Superficial Femoral Arteries in PAD Subjects Scheduled for DSA
ClinicalTrials.gov ID: NCT00707876
Acronym / sponsor ID: FER-PAD-001
Conditions: Peripheral Arterial Disease (PAD)
Keywords: Peripheral arterial disease (PAD), Magnetic Resonance Angiography (MRA), Magnetic Resonance Imaging (MRI), imaging agent or biomarker
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 1 Sep 2008 (actual)
Primary completion: 2 Jul 2010 (actual)
Study completion: 15 Aug 2020 (actual)
First posted: 1 Jul 2008 (estimated)
Results: Posted 16 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort 1	Experimental	Drug: ferumoxytol1.0 mg/kg IV ferumoxytol versus non-contrast MRA
Cohort 2	Experimental	Drug: ferumoxytol2.5 mg/kg IV ferumoxytol versus non-contrast MRA
Cohort 3	Experimental	Drug: ferumoxytol4.0 mg/kg IV ferumoxytol versus non-contrast MRA

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subjects with symptoms of PAD
Scheduled for DSA

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ferumoxytol1.0 mg/kg IV ferumoxytol	Drug	Cohort 1
ferumoxytol2.5 mg/kg IV ferumoxytol	Drug	Cohort 2
ferumoxytol4.0 mg/kg IV ferumoxytol	Drug	Cohort 3

Primary outcome

Segment-level Sensitivity and Specificity of VE-MRI at 3 Ferumoxytol Dosing Levels and Differences in Sensitivity and Specificity by Dose Group
Time frame: 3 weeks
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.
Segment-level Sensitivity and Specificity of Noncontrast MRA at 3 Ferumoxytol Dosing Levels and Difference From Sensitivity by Dose Group
Time frame: 3 weeks
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.

6 secondary outcomes

Segment-level Positive and Negative Predictive Values of VE-MRI Using Ferumoxytol at 3 Dosing Levels
Time frame: 3 weeks
Segment-level Positive and Negative Predictive Values of Noncontrast MRA
Time frame: 3 weeks
Segment-level Total Percent, Positive Percent Between VE-MRI and Noncontrast MRA
Time frame: 3 weeks
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
Time frame: 3 weeks
Segment-level Negative Percent Agreements VE-MRI and Noncontrast MRA
Time frame: 3 weeks
Segment-level Total Percent, Kappa Statistics Between VE-MRI and Noncontrast MRA
Time frame: 3 weeks

Results and safety

Results posted to the registry on 16 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	40	39
Cohort 2	39	39
Cohort 3	40	37

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

Time frame: 3 weeks. Number (95% Confidence Interval). Unit: percent agreement

Measure	Cohort 1 n = 39	Cohort 2 n = 39	Cohort 3 n = 37
Reader 1: Sensitivity	71.8 (61.3 to 82.4)	76.8 (65.8 to 87.8)	81.8 (71.2 to 92.5)
Reader 1: Specificity	71.2 (59.7 to 82.8)	76.5 (66.6 to 86.4)	75.2 (66.3 to 84.1)
Reader 2: Sensitivity	74.6 (63.1 to 86.2)	82.6 (73.0 to 92.2)	71.2 (58.2 to 84.3)
Reader 2: Specificity	66.4 (55.2 to 77.7)	77.2 (68.6 to 85.7)	61.7 (51.3 to 72.1)
Reader 3: Sensitivity	90.1 (81.9 to 98.4)	87.0 (77.4 to 96.5)	86.4 (76.6 to 96.2)
Reader 3: Specificity	59.6 (48.4 to 70.7)	70.5 (60.3 to 80.6)	61.0 (50.4 to 71.6)

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

Time frame: 3 weeks. Number (95% Confidence Interval). Unit: percentage

Measure	Cohort 1 n = 39	Cohort 2 n = 39	Cohort 3 n = 37
Reader 1: Sensitivity	49.3 (34.2 to 64.4)	53.6 (38.0 to 69.3)	50.0 (34.3 to 65.7)
Reader 1: Specificity	54.1 (42.8 to 65.4)	46.3 (32.6 to 60.0)	54.6 (40.0 to 69.3)
Reader 2: Sensitivity	63.4 (50.9 to 75.8)	58.0 (43.5 to 72.5)	54.5 (40.0 to 69.1)
Reader 2: Specificity	54.8 (41.6 to 68.0)	47.7 (33.7 to 61.6)	56.7 (43.6 to 69.9)
Reader 3: Sensitivity	76.1 (65.1 to 87.0)	76.8 (64.6 to 89.0)	69.7 (56.1 to 83.3)
Reader 3: Specificity	55.5 (45.1 to 65.8)	57.7 (46.1 to 69.3)	63.8 (53.3 to 74.4)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	5 of 40 (12.5%)	2 of 40 (5%)	0 of 40
Cohort 2	2 of 39 (5.1%)	0 of 39 (0%)	0 of 39
Cohort 3	4 of 40 (10%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Peripheral Arterial Disease (PAD)

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Strauss, MD study director

AMAG Pharmaceuticals, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ferumoxytol in people with Peripheral Arterial Disease (PAD), run by AMAG Pharmaceuticals, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Segment-level Sensitivity and Specificity of VE-MRI at 3 Ferumoxytol Dosing Levels and Differences in Sensitivity and Specificity by Dose Group (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00707876.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.