Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis in the Calf and/or Pedal Arteries

Stenosis Clinical Trial

Official title:

Multicenter, Open-label Study of the Safety (Open-label) and Efficacy (Open-label and Blinded Reader) of a Single Administration of Approximately 0.1 mmol/kg of Magnevist® Injection-enhanced Magnetic Resonance Arteriography (MRA) and 2-dimensional-time-of-flight (2D-TOF) MRA in Patients With Known or Suspected Disease of the Calf and/or Pedal Arteries Undergoing MRA of the Calf and Pedal Arteries With Intra-arterial Digital Subtraction Arteriography (i.a. DSA) as the Standard of Reference.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309075
• Other study ID #: 91251
• Secondary ID: 307260
• Status: Completed
• Phase: Phase 3
• First received: March 30, 2006
• Last updated: December 29, 2014
• Start date: December 2003
• Est. completion date: November 2004

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: Ministry of HealthCanada: Health CanadaChile: Ministry of Health (ISP)Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the calf and foot arteries. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.

Description:

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has known or suspected disease of the calf and/or pedal arteries

• Is scheduled for X-ray angiography

Exclusion Criteria:

• Has any contraindication to magnetic resonance imaging

• Is scheduled for any procedure before the X-ray angiography

• Had previously had stents placed bilaterally in the calf and/or foot arteries

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Constriction, Pathologic
• Stenosis

Intervention

Drug:
• Gadopentetate dimeglumine (Magnevist)
Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by blinded reader		Image creation after injection - evaluation at blind read
Secondary	Diagnostic confidence		At blinded and/or open label read of the images
Secondary	Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by open label reader		At blinded and/or open label read of the images
Secondary	Location and matching of stenosis		At blinded and/or open label read of the images
Secondary	Image quality		At blinded and/or open label read of the images
Secondary	Image evaluability and presence of artefacts		At blinded and/or open label read of the images
Secondary	Ability to visualize arteries		At blinded and/or open label read of the images
Secondary	Exact categorization of stenosis		At blinded and/or open label read of the images
Secondary	Number of evaluable arteries		At blinded and/or open label read of the images
Secondary	Duration of 2D-TOF and MRA		At blinded and/or open label read of the images
Secondary	Artery appropriate for bypass		At blinded and/or open label read of the images
Secondary	Patient management		from baseline to 24 hours follow-up
Secondary	Safety		from baseline to 24 hours follow-up

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