Intracranial AneurysmsPhase 4MAPSNCT00396981
MAPS Trial: Matrix And Platinum Science
A Phase 4 study testing Matrix 2® coils for endovascular aneurysm occlusion and GDC® coils for endovascular aneurysm occlusion in people with Intracranial Aneurysms, run by Stryker Neurovascular at 43 sites in 11 countries.
Trial summary
Primary Objectives: To establish Target Aneurysm Recurrence (TAR) rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms. TAR is defined as clinically relevant recurrence resulting in: target aneurysm reintervention, rupture/re-rupture and/or death from an unknown cause. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- Matrix 2® coils for endovascular aneurysm occlusion and GDC® coils for endovascular aneurysm occlusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 626 participants
- Where
- 43 sitesin 11 countries
- Study dates
- Mar 2007to Mar 2015
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is between 18 and 80 years of age (inclusive).
- Patient has a documented untreated intracranial saccular aneurysm 4-20 mm diameter angiographic lumen, ruptured or unruptured, suitable for embolization with coils.
- Both GDC® Coils and Matrix 2® Coils (Every attempt should be made to treat with as much randomized coil type as possible to achieve optimal occlusion.) are treatment options (all shapes allowed with exception of GDC VortX Coil).
- Target aneurysm can be adequately coiled at index procedure (NO staged coiling procedures). If a Neuroform stent is to be placed during a separate preliminary procedure, then screening and enrollment for the coiling procedure must take place after the stenting procedure is completed.
- Target aneurysm morphology allows for adequate retention of coils within the aneurysmal sac without occlusion of the parent artery, as determined by the treating physician.
- Patient (or patient's legally authorized representative for centers in the United States) has provided written informed consent.
- Patient is willing and able to comply with protocol follow-up requirements.
Who cannot join
- Patient is < 18 or > 80 years old.
- Target aneurysm is not saccular in nature (mycotic, fusiform, dissecting).
- Target aneurysm is > 20 mm maximum luminal dimension, < 4 mm maximum luminal dimension.
- Target aneurysm has been previously treated by surgery or endovascular therapy.
- Target aneurysm is in the physician's estimation unlikely to be successfully treated by endovascular techniques.
- Patient presents as Hunt and Hess grade IV or V for a ruptured aneurysm.
Show all 16Show fewer
- Patient presents with Modified Rankin Score 4 or 5 at baseline.
- Patient is concurrently enrolled in another investigational drug or device study unless permission is granted by the sponsor.
- Patient has known hypersensitivity to Polyglycolic Polylactic Acid (PGLA), platinum, nickel, stainless steel or structurally related compounds found in Matrix 2® Coils and/or GDC® Coils.
- Patients who have had or could have a severe reaction to contrast agents that cannot be adequately pre-medicated prior to the coiling procedure.
- Patients who are unable to complete scheduled follow up assessments at the enrolling center due to limited life expectancy (< 12 months), comorbidities or geographical considerations.
- Planned use of adjunctive therapy stents except Neuroform is not allowed.
- Patients with Moya-Moya disease, AVMs, AV fistula, intracranial tumors, intracranial hematoma (unrelated to target aneurysm), significant atherosclerotic stenosis, tortuousity or other conditions preventing access to the target aneurysm.
- Patients with multiple aneurysms.
- Target aneurysm with significant thrombosis that may increase the likelihood of recanalization at the discretion of the investigator.
- Female patient has a positive pregnancy assessment at baseline.
Trial locations and contacts
43 sites in 11 countries.
43 sites in 11 countries
United States26 sites
University of New Mexico Department of Neurosurgery
Albuquerque, New Mexico, 87131
University of Maryland
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
Carolina Neurosurgery & Spine Associates, PA
Charlotte, North Carolina, 28207
Rush Presbyterian
Chicago, Illinois, 60640
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8896
Methodist Hospital
Houston, Texas, 77030
The Universtiy of Iowa
Iowa City, Iowa, 52242
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Fort Sanders Regional Medical Center
Knoxville, Tennessee, 37916
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
University of Wisconsin Hospital and Center
Madison, Wisconsin, 53792
Yale-New Haven Hospital
New Haven, Connecticut, 06510
Mercy Health Center
Oklahoma City, Oklahoma, 73120
St. Joseph's Hospital Barrow Neurological Institute
Phoenix, Arizona, 85013
OHSU
Portland, Oregon, 97239
St. Joseph's Hospital
Saint Paul, Minnesota, 55104
University of Washington Harborview Medical Center
Seattle, Washington, 98104
Providence Detroit
Southfield, Michigan, 48075
Sacred Heart Providence
Spokane, Washington, 99204
Barnes Jewish Mallinckrodt Institute of Radiology
St Louis, Missouri, 63110
Stony Brook Medical Center
Stony Brook, New York, 11794
Tucson Medical Center
Tucson, Arizona, 85712
University of Massachusetts Worcester
Worcester, Massachusetts, 01655
Germany4 sites
Klinikum Augsburg
Augsburg, 86156
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106
Asklepios Klinik Altona
Hamburg, 22763
Universitaetsklinikum des Saarlandes
Homburg/Saar, 66421
Spain4 sites
Hospital General
Alicante
Hospital Clinico Y provincial
Barcelona
Hospital Donostia
Donostia / San Sebastian
Clinica Ntra Sra Del Rosario Hospital Ruber Internacional
Madrid, 28056
United Kingdom2 sites
The Walton Centre
Fazakerley, Liverpool, L9 7LJ
Newcastle General Hospital Department of Neuroradiology
Tyne and Wear, NE4 6BE
Canada1 site
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4
Mexico1 site
Instituto Nacional de Neurologia e Neurocirurgia
Mexico City, Mexico City, 14269
Turkey (Türkiye)1 site
Istanbul University Cerrahpaşa Tıp Fakültesi
Kocamustafapaşa, Istanbul, 34300
About this study
Official title: A Prospective, Randomized, Multicenter Trial Investigating Matrix 2® and GDC® Detachable Coils for the Treatment of Intracranial Saccular Aneurysms
Primary Objectives:
- To establish Target Aneurysm Recurrence (TAR) rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms. TAR is defined as clinically relevant recurrence resulting in: target aneurysm reintervention, rupture/re-rupture and/or death from an unknown cause.
- To correlate defined angiographic endpoints with TAR rates and assess their predictive value, thereby providing a framework to establish clinically relevant endpoints for future studies.
Read more
Secondary Objectives:
- To evaluate device characteristics, incidence and severity of device-related adverse events, including death, neurological deterioration and changes in functional abilities.
- To establish angiographic recurrence rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms.
- To explore an experimental, quantitative and volumetric endpoint and correlate these with existing qualitative assessments.
Read the detailed description
The endovascular treatment of intracranial aneurysms has become an accepted alternative to surgical repair given the many recent advances with neurointerventional devices and procedures. The introduction of GDC coils in 1993 provided physicians and their patients a less invasive treatment option. Additionally, the results of two large international trials, ISAT and ISUIA, have shown the benefits of endovascular treatment over surgery for treatment of specific types of aneurysms. One limitation of endovascular coil embolization is aneurysm recurrence or recanalization which is not infrequently observed angiographically at follow up. Aneurysm recanalization may be a result of aneurysm morphology, anatomic location and flow orientation, aneurysm regrowth or the degree of coil compaction. Despite the widespread adoption of endovascular aneurysm coiling, there remains much to be learned about the efficacy and optimization of this treatment modality.
The goal of endovascular embolization of intracranial aneurysms is to prevent rupture or re-rupture. Fortunately, the incidence of aneurysm rupture following coil embolization is very low. Follow-up angiographic analysis to evaluate the occlusion and stability of the treated aneurysm provides a surrogate endpoint against which to weigh the likelihood of rupture/re-rupture. However, angiographic interpretation is subjective, operator dependent and can be influenced by multiple confounding variables.
The MAPS trial will examine Target Aneurysm Recurrence Rates: clinically relevant recurrence rates resulting in target aneurysm reintervention, rupture/re-rupture and/or death from an unknown cause for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms. The trial will compare TAR rates to recurrences measured by angiographic analysis and assess the utility of angiographic analysis for predicting clinically relevant recurrences.
- Conditions
- Intracranial Aneurysms
- Being tested
- Matrix 2® coils for endovascular aneurysm occlusion, GDC® coils for endovascular aneurysm occlusion
- Keywords
- Intracranial saccular aneurysms, Endovascular coiling therapy, Retreatment, Raymond scale, Matrix, GDC, Guglielmi Detachable Coil
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matrix 2® coils for endovascular aneurysm occlusionDevice
endovascular aneurysm occlusion coil
GDC® coils for endovascular aneurysm occlusionDevice
endovascular aneurysm occlusion coil
| Study group | Role | What they receive |
|---|---|---|
| Matrix 2® Coils | Active comparator | Matrix 2® Coils for endovascular aneurysm occlusion Receives: Device: Matrix 2® coils for endovascular aneurysm occlusion |
| GDC® Coils | Active comparator | GDC® Coils for endovascular aneurysm occlusion Receives: Device: GDC® coils for endovascular aneurysm occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause.
Measured: 12 months
Secondary outcomes (6)
Angiographic Assessments
Number of participants with angiographic assessment of "complete obliteration".
Measured: Reintervention or 12 months
Neurological Assessments
The changes in modified Rankin Scores from pre-procedure to 12-month were measured. the outcome below reflects "same or better".
Measured: 12 months
Technical Procedure Success
Measured: Post-procedure
Target Aneurysm Recurrence
Measured: 2 years
Target Aneurysm Recurrence
Measured: 3 years
Target Aneurysm Recurrence
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2006 (estimated)
- Study startMar 2007
- Primary completionJan 2011
- Study completionMar 2015
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 626 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- S. Claiborne Johnston, MD, PhD, Principal investigator, University of California, San Francisco, CACameron McDougall, MD, Principal investigator, Barrow Neurological Institute, Phoenix, AZAnil Gholkar, MD, Principal investigator, Newcastle Upon Tyne Hospitals, NHS Trust, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396981
- Sponsor's protocol ID
- T4902
- Other IDs
- BSC0015
- Acronym
- MAPS
- Status last verified
- Jan 2016
- First submitted
- 6 Nov 2006
- Last updated
- 17 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McDougall CG, Johnston SC, Gholkar A, Barnwell SL, Vazquez Suarez JC, Masso Romero J, Chaloupka JC, Bonafe A, Wakhloo AK, Tampieri D, Dowd CF, Fox AJ, Imm SJ, Carroll K, Turk AS; MAPS Investigators. Bioactive versus bare platinum coils in the treatment of intracranial aneurysms: the MAPS (Matrix and Platinum Science) trial. AJNR Am J Neuroradiol. 2014 May;35(5):935-42. doi: 10.3174/ajnr.A3857. Epub 2014 Jan 30.
PubMed 24481333Hetts SW, Turk A, English JD, Dowd CF, Mocco J, Prestigiacomo C, Nesbit G, Ge SG, Jin JN, Carroll K, Murayama Y, Gholkar A, Barnwell S, Lopes D, Johnston SC, McDougall C; Matrix and Platinum Science Trial Investigators. Stent-assisted coiling versus coiling alone in unruptured intracranial aneurysms in the matrix and platinum science trial: safety, efficacy, and mid-term outcomes. AJNR Am J Neuroradiol. 2014 Apr;35(4):698-705. doi: 10.3174/ajnr.A3755. Epub 2013 Nov 1.
PubMed 24184523
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter Trial Investigating Matrix 2® and GDC® Detachable Coils for the Treatment of Intracranial Saccular Aneurysms
- ClinicalTrials.gov ID
- NCT00396981
- Acronym / sponsor ID
- MAPS / T4902
- Conditions
- Intracranial Aneurysms
- Keywords
- Intracranial saccular aneurysms, Endovascular coiling therapy, Retreatment, Raymond scale, Matrix, GDC, Guglielmi Detachable Coil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 626 participants (actual)
- Lead sponsor
- Stryker NeurovascularIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Nov 2006 (estimated)
- Results
- Posted 18 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- To establish Target Aneurysm Recurrence (TAR) rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms. TAR is defined as clinically relevant recurrence resulting in: target aneurysm reintervention, rupture/re-rupture and/or death from an unknown cause.
- To correlate defined angiographic endpoints with TAR rates and assess their predictive value, thereby providing a framework to establish clinically relevant endpoints for future studies.
Secondary Objectives:
- To evaluate device characteristics, incidence and severity of device-related adverse events, including death, neurological deterioration and changes in functional abilities.
- To establish angiographic recurrence rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms.
- To explore an experimental, quantitative and volumetric endpoint and correlate these with existing qualitative assessments.
Detailed description
The endovascular treatment of intracranial aneurysms has become an accepted alternative to surgical repair given the many recent advances with neurointerventional devices and procedures. The introduction of GDC coils in 1993 provided physicians and their patients a less invasive treatment option. Additionally, the results of two large international trials, ISAT and ISUIA, have shown the benefits of endovascular treatment over surgery for treatment of specific types of aneurysms. One limitation of endovascular coil embolization is aneurysm recurrence or recanalization which is not infrequently observed angiographically at follow up. Aneurysm recanalization may be a result of aneurysm morphology, anatomic location and flow orientation, aneurysm regrowth or the degree of coil compaction. Despite the widespread adoption of endovascular aneurysm coiling, there remains much to be learned about the efficacy and optimization of this treatment modality.
The goal of endovascular embolization of intracranial aneurysms is to prevent rupture or re-rupture. Fortunately, the incidence of aneurysm rupture following coil embolization is very low. Follow-up angiographic analysis to evaluate the occlusion and stability of the treated aneurysm provides a surrogate endpoint against which to weigh the likelihood of rupture/re-rupture. However, angiographic interpretation is subjective, operator dependent and can be influenced by multiple confounding variables.
The MAPS trial will examine Target Aneurysm Recurrence Rates: clinically relevant recurrence rates resulting in target aneurysm reintervention, rupture/re-rupture and/or death from an unknown cause for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms. The trial will compare TAR rates to recurrences measured by angiographic analysis and assess the utility of angiographic analysis for predicting clinically relevant recurrences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matrix 2® Coils | Active comparator | Device: Matrix 2® coils for endovascular aneurysm occlusionMatrix 2® Coils for endovascular aneurysm occlusion |
| GDC® Coils | Active comparator | Device: GDC® coils for endovascular aneurysm occlusionGDC® Coils for endovascular aneurysm occlusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is between 18 and 80 years of age (inclusive).
- Patient has a documented untreated intracranial saccular aneurysm 4-20 mm diameter angiographic lumen, ruptured or unruptured, suitable for embolization with coils.
- Both GDC® Coils and Matrix 2® Coils (Every attempt should be made to treat with as much randomized coil type as possible to achieve optimal occlusion.) are treatment options (all shapes allowed with exception of GDC VortX Coil).
- Target aneurysm can be adequately coiled at index procedure (NO staged coiling procedures). If a Neuroform stent is to be placed during a separate preliminary procedure, then screening and enrollment for the coiling procedure must take place after the stenting procedure is completed.
- Target aneurysm morphology allows for adequate retention of coils within the aneurysmal sac without occlusion of the parent artery, as determined by the treating physician.
Key exclusion criteria (16 listed)
- Patient is < 18 or > 80 years old.
- Target aneurysm is not saccular in nature (mycotic, fusiform, dissecting).
- Target aneurysm is > 20 mm maximum luminal dimension, < 4 mm maximum luminal dimension.
- Target aneurysm has been previously treated by surgery or endovascular therapy.
- Target aneurysm is in the physician's estimation unlikely to be successfully treated by endovascular techniques.
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 |
|---|---|---|
| Matrix 2® coils for endovascular aneurysm occlusionendovascular aneurysm occlusion coil | Device | Matrix 2® Coils |
| GDC® coils for endovascular aneurysm occlusionendovascular aneurysm occlusion coil | Device | GDC® Coils |
Primary outcome
Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause.
Time frame: 12 months
6 secondary outcomes
Angiographic Assessments
Time frame: Reintervention or 12 months
Neurological Assessments
Time frame: 12 months
Technical Procedure Success
Time frame: Post-procedure
Target Aneurysm Recurrence
Time frame: 2 years
Target Aneurysm Recurrence
Time frame: 3 years
Target Aneurysm Recurrence
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24481333McDougall CG, Johnston SC, Gholkar A, Barnwell SL, Vazquez Suarez JC, Masso Romero J, Chaloupka JC, Bonafe A, Wakhloo AK, Tampieri D, Dowd CF, Fox AJ, Imm SJ, Carroll K, Turk AS; MAPS Investigators. Bioactive versus bare platinum coils in the treatment of intracranial aneurysms: the MAPS (Matrix and Platinum Science) trial. AJNR Am J Neuroradiol. 2014 May;35(5):935-42. doi: 10.3174/ajnr.A3857. Epub 2014 Jan 30.
- Derived from this study: PubMed 24184523Hetts SW, Turk A, English JD, Dowd CF, Mocco J, Prestigiacomo C, Nesbit G, Ge SG, Jin JN, Carroll K, Murayama Y, Gholkar A, Barnwell S, Lopes D, Johnston SC, McDougall C; Matrix and Platinum Science Trial Investigators. Stent-assisted coiling versus coiling alone in unruptured intracranial aneurysms in the matrix and platinum science trial: safety, efficacy, and mid-term outcomes. AJNR Am J Neuroradiol. 2014 Apr;35(4):698-705. doi: 10.3174/ajnr.A3755. Epub 2013 Nov 1.
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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.
S. Claiborne Johnston, MD, PhD principal investigator
University of California, San Francisco, CA
Cameron McDougall, MD principal investigator
Barrow Neurological Institute, Phoenix, AZ
Anil Gholkar, MD principal investigator
Newcastle Upon Tyne Hospitals, NHS Trust, UK
43 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Matrix 2® coils for endovascular aneurysm occlusion and GDC® coils for endovascular aneurysm occlusion in people with Intracranial Aneurysms, run by Stryker Neurovascular at 43 sites in 11 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 7 inclusion and 16 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 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Germany, Spain, United Kingdom, Australia and 6 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 18 Mar 2014). 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?
Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause. (time frame: 12 months). 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 NCT00396981, which also lists 2 linked publications.
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 17 Feb 2016.