NCT00185276

Brief 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 infrarenal aorta and peripheral arteries. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

First QC Date

September 10, 2005

Last Update Submit

December 29, 2014

Conditions

Peripheral Vascular Disease

Keywords

Structural abnormalities of the infrarenal aorta and peripheral arteries

Outcome Measures

Primary Outcomes (1)

  • Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant disease

    Image creation after injection - evaluation at blind read

Secondary Outcomes (12)

  • Diagnostic confidence

    At blinded or/and open label read of images

  • Visual assessment of stenosis

    At blinded or/and open label read of images

  • Difference in degree of stenosis

    At blinded or/and open label read of images

  • Other diagnostic findings

    At blinded or/and open label read of images

  • Image quality

    At blinded or/and open label read of images

  • +7 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Arm 2

EXPERIMENTAL
Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Interventions

Gadopentetate dimeglumine (Magnevist, BAY86-4882)DRUG

Single intravenous injection on the study day: lower dose corresponding approx. 0.1 mmol/kg body weight

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has known or suspected peripheral vascular disease
  • Is scheduled for X-ray angiography

You may not qualify if:

  • 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 region to be imaged

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Gadolinium DTPA

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pentetic AcidPolyaminesAminesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsCoordination Complexes

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 16, 2005

Study Start

March 1, 2003

Study Completion

August 1, 2004

Last Updated

December 30, 2014

Record last verified: 2014-12