StenosisPhase 3NCT00309075
Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis in the Calf and/or Pedal Arteries
A Phase 3 study testing Gadopentetate dimeglumine (Magnevist) in people with Stenosis, run by Bayer.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stenosis
- What is being tested?
- Gadopentetate dimeglumine (Magnevist)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Nov 2004
- 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
- Has known or suspected disease of the calf and/or pedal arteries
- Is scheduled for X-ray angiography
Who cannot join
- 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
About this study
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.
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.
Read the detailed 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.
- Conditions
- Stenosis
- Being tested
- Gadopentetate dimeglumine (Magnevist)
- Keywords
- Stenosis of the calf and/or pedal arteries
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadopentetate dimeglumine (Magnevist)Drug
Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Gadopentetate dimeglumine (Magnevist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by blinded reader
Measured: Image creation after injection - evaluation at blind read
Secondary outcomes (12)
Diagnostic confidence
Measured: At blinded and/or open label read of the images
Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by open label reader
Measured: At blinded and/or open label read of the images
Location and matching of stenosis
Measured: At blinded and/or open label read of the images
Image quality
Measured: At blinded and/or open label read of the images
Image evaluability and presence of artefacts
Measured: At blinded and/or open label read of the images
Ability to visualize arteries
Measured: At blinded and/or open label read of the images
Exact categorization of stenosis
Measured: At blinded and/or open label read of the images
Number of evaluable arteries
Measured: At blinded and/or open label read of the images
Duration of 2D-TOF and MRA
Measured: At blinded and/or open label read of the images
Artery appropriate for bypass
Measured: At blinded and/or open label read of the images
Patient management
Measured: from baseline to 24 hours follow-up
Safety
Measured: from baseline to 24 hours follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2006 (estimated)
- Study startDec 2003
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StenosisStudies 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309075
- Sponsor's protocol ID
- 91251
- Other IDs
- 307260
- Status last verified
- Dec 2014
- First submitted
- 30 Mar 2006
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00309075
- Acronym / sponsor ID
- 91251
- Conditions
- Stenosis
- Keywords
- Stenosis of the calf and/or pedal arteries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Study completion
- Nov 2004 (actual)
- First posted
- 31 Mar 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 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.
Detailed 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.
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: Gadopentetate dimeglumine (Magnevist) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has known or suspected disease of the calf and/or pedal arteries
- Is scheduled for X-ray angiography
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Gadopentetate dimeglumine (Magnevist)Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day | Drug | Arm 1 |
Primary outcome
Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by blinded reader
Time frame: Image creation after injection - evaluation at blind read
12 secondary outcomes
Diagnostic confidence
Time frame: At blinded and/or open label read of the images
Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by open label reader
Time frame: At blinded and/or open label read of the images
Location and matching of stenosis
Time frame: At blinded and/or open label read of the images
Image quality
Time frame: At blinded and/or open label read of the images
Image evaluability and presence of artefacts
Time frame: At blinded and/or open label read of the images
Ability to visualize arteries
Time frame: At blinded and/or open label read of the images
Exact categorization of stenosis
Time frame: At blinded and/or open label read of the images
Number of evaluable arteries
Time frame: At blinded and/or open label read of the images
Duration of 2D-TOF and MRA
Time frame: At blinded and/or open label read of the images
Artery appropriate for bypass
Time frame: At blinded and/or open label read of the images
Patient management
Time frame: from baseline to 24 hours follow-up
Safety
Time frame: from baseline to 24 hours follow-up
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 30 Dec 2014.
Related trials for Stenosis
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gadopentetate dimeglumine (Magnevist) in people with Stenosis, run by Bayer.
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 3 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 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by blinded reader (time frame: Image creation after injection - evaluation at blind read). 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 30 Dec 2014.