Peripheral Vascular DiseasesPhase 3NCT00296855
Comparison Study of Vasovist® Magnetic Resonance Angiography (MRA) and an MRA With a Conventional Extracellular Contrast Agent With X-ray Angiography in Patients With Peripheral Artery Disease
A Phase 3 study testing Vasovist (BAY86-5283, MS-325) in people with Peripheral Vascular Diseases, run by Bayer at 26 sites in 6 countries.
Trial summary
The particular aim of this study is the comparison of the diagnostic results of MRA images upon application of Vasovist (gadofosveset), a contrast agent not yet available on the market, with the MRA images upon application of a conventional extracellular contrast agent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- Vasovist (BAY86-5283, MS-325)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 26 sitesin 6 countries
- Study dates
- Feb 2006to Feb 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patients with a certain circulation disorder (aortoiliac disease Fontaine-stage IIb / IV) and an indication for the evaluation of the peripheral run-off arteries from the infrarenal aorta to the calves
- Patients who are scheduled for X-ray angiography and magnetic resonance angiography (MRA) of the arteries mentioned above
- Patients who have had a contrast-enhanced MRA examination of the arteries mentioned above using a standard extracellular contrast agent performed within 1 - 7 days prior to the study MRA examination
Who cannot join
- Less than 18 years of age
- Women who are pregnant, breast feeding or who are of childbearing potential and have not had a negative urine pregnancy test the same day as the study MRA examination
- Requiring immediate therapy for their vascular disease or in whom conduct of all three angiographic procedures is not possible
- Not being able to remain lying down for at least 45 - 60 min
- Patients with a history of serious allergic reactions to any allergen including drugs and contrast agents or with a history of sickle cell disease or other hemolytic anemia
- Having any contraindication to magnetic resonance imaging (MRI) examination or specifically for MRA (e.g. pacemaker, recent wound clips, and severe claustrophobia)
Trial locations and contacts
26 sites in 6 countries.
26 sites in 6 countries
Germany9 sites
Study site
Berlin, State of Berlin, 13353
Study site
Bonn, North Rhine-Westphalia, 53105
Study site
Cologne, North Rhine-Westphalia, 50931
Study site
Essen, North Rhine-Westphalia, 45147
Study site
Frankfurt am Main, Hesse, 60389
Study site
Frankfurt am Main, Hesse, 60596
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20251
Study site
Mainz, Rhineland-Palatinate, 55131
Study site
Münster, North Rhine-Westphalia, 48149
Argentina4 sites
Study site
Buenos Aires, Buenos Aires
Study site
Buenos Aires, Buenos Aires F.D., C1082ACA
Study site
Buenos Aires, Buenos Aires F.D., C1428DDO
Study site
Lornas de Zamora, Buenos Aires, B1832BQS
Austria4 sites
Study site
Graz, Styria, 8036
Study site
Sankt Pölten, Lower Austria, 3100
Study site
Vienna, State of Vienna, 1021
Study site
Vienna, State of Vienna, 1090
Brazil4 sites
Study site
Curitiba, Paraná, 80060-900
Study site
Rio de Janeiro, Rio de Janeiro, 22649
Study site
São Paulo, São Paulo, 01323-001
Study site
São Paulo, São Paulo, 05403-900
Mexico3 sites
Study site
Mexico D. F., 06760
Study site
México D.F., 10700
Study site
Monterrey, Nuevo León, 64460
About this study
Official title: Intra-individual Open-label Multicenter Comparison Study of Magnetic Resonance Angiography (MRA) With the Blood Pool Contrast Agent Vasovist® and a Conventional Extracellular Contrast Agent With Intra-arterial Digital Subtraction Angiography (i.a. DSA) in Patients With Peripheral Artery Disease
The particular aim of this study is the comparison of the diagnostic results of MRA images upon application of Vasovist (gadofosveset), a contrast agent not yet available on the market, with the MRA images upon application of a conventional extracellular contrast agent. A catheter angiography, which will be performed as a routine diagnostic procedure for vascular diseases, will serve as an evaluation standard.
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- Vasovist (BAY86-5283, MS-325)
- Keywords
- Peripheral artery disease
- Medical subject headings
- Peripheral Vascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasovist (BAY86-5283, MS-325)Drug
All patients receive a single IV bolus injection of Vasovist at a dose of 0,03 mmol/kg BW at a flowrate of 0,5 mL/sec, followed by a saline flush of at least 30 mL
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Vasovist (BAY86-5283, MS-325) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic potential of Vasovist enhanced MRA
Measured: Imaging after baseline visit, before and after Vasovist injection
Secondary outcomes (5)
Comparison of the quantitative assessment and the qualitative assessment of arterial stenosis/disease as compared to X-ray angiography
Measured: After imaging
Quantitative assessment of vessel enhancement
Measured: After imaging
Qualitative assessment of disease
Measured: After imaging
Qualitative assessment of plaque morphology
Measured: After imaging
Evaluation of quality of vascular anatomy and delineation of vessel wall, venous enhancement and diagnostic potential of venous enhancement
Measured: After imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296855
- Sponsor's protocol ID
- 91463
- Other IDs
- EudraCT No. 2005-002547-66, 308861
- Status last verified
- Apr 2010
- First submitted
- 24 Feb 2006
- Last updated
- 23 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-individual Open-label Multicenter Comparison Study of Magnetic Resonance Angiography (MRA) With the Blood Pool Contrast Agent Vasovist® and a Conventional Extracellular Contrast Agent With Intra-arterial Digital Subtraction Angiography (i.a. DSA) in Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT00296855
- Acronym / sponsor ID
- 91463
- Conditions
- Peripheral Vascular Diseases
- Keywords
- Peripheral artery disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Study completion
- Feb 2007 (actual)
- First posted
- 27 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The particular aim of this study is the comparison of the diagnostic results of MRA images upon application of Vasovist (gadofosveset), a contrast agent not yet available on the market, with the MRA images upon application of a conventional extracellular contrast agent. A catheter angiography, which will be performed as a routine diagnostic procedure for vascular diseases, will serve as an evaluation standard.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Vasovist (BAY86-5283, MS-325) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a certain circulation disorder (aortoiliac disease Fontaine-stage IIb / IV) and an indication for the evaluation of the peripheral run-off arteries from the infrarenal aorta to the calves
- Patients who are scheduled for X-ray angiography and magnetic resonance angiography (MRA) of the arteries mentioned above
- Patients who have had a contrast-enhanced MRA examination of the arteries mentioned above using a standard extracellular contrast agent performed within 1 - 7 days prior to the study MRA examination
Key exclusion criteria (6 listed)
- Less than 18 years of age
- Women who are pregnant, breast feeding or who are of childbearing potential and have not had a negative urine pregnancy test the same day as the study MRA examination
- Requiring immediate therapy for their vascular disease or in whom conduct of all three angiographic procedures is not possible
- Not being able to remain lying down for at least 45 - 60 min
- Patients with a history of serious allergic reactions to any allergen including drugs and contrast agents or with a history of sickle cell disease or other hemolytic anemia
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 |
|---|---|---|
| Vasovist (BAY86-5283, MS-325)All patients receive a single IV bolus injection of Vasovist at a dose of 0,03 mmol/kg BW at a flowrate of 0,5 mL/sec, followed by a saline flush of at least 30 mL | Drug | Arm 1 |
Primary outcome
Diagnostic potential of Vasovist enhanced MRA
Time frame: Imaging after baseline visit, before and after Vasovist injection
5 secondary outcomes
Comparison of the quantitative assessment and the qualitative assessment of arterial stenosis/disease as compared to X-ray angiography
Time frame: After imaging
Quantitative assessment of vessel enhancement
Time frame: After imaging
Qualitative assessment of disease
Time frame: After imaging
Qualitative assessment of plaque morphology
Time frame: After imaging
Evaluation of quality of vascular anatomy and delineation of vessel wall, venous enhancement and diagnostic potential of venous enhancement
Time frame: After imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2010.
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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.
Bayer Study Director study director
Bayer
26 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vasovist (BAY86-5283, MS-325) in people with Peripheral Vascular Diseases, run by Bayer at 26 sites in 6 countries.
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 3 inclusion and 6 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 23 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany, Argentina, Austria, Brazil, Mexico and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic potential of Vasovist enhanced MRA (time frame: Imaging after baseline visit, before and after Vasovist injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2010.