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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00396981
Registration number
NCT00396981
Ethics application status
Date submitted
6/11/2006
Date registered
8/11/2006
Date last updated
17/02/2016
Titles & IDs
Public title
MAPS Trial: Matrix And Platinum Science
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Scientific title
A Prospective, Randomized, Multicenter Trial Investigating Matrix 2® and GDC® Detachable Coils for the Treatment of Intracranial Saccular Aneurysms
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Secondary ID [1]
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BSC0015
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Secondary ID [2]
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T4902
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Universal Trial Number (UTN)
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Trial acronym
MAPS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Intracranial Aneurysms
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Matrix 2® coils for endovascular aneurysm occlusion
Treatment: Devices - GDC® coils for endovascular aneurysm occlusion
Active Comparator: Matrix 2® Coils - Matrix 2® Coils for endovascular aneurysm occlusion
Active Comparator: GDC® Coils - GDC® Coils for endovascular aneurysm occlusion
Treatment: Devices: Matrix 2® coils for endovascular aneurysm occlusion
endovascular aneurysm occlusion coil
Treatment: Devices: GDC® coils for endovascular aneurysm occlusion
endovascular aneurysm occlusion coil
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause.
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Assessment method [1]
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Angiographic Assessments
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Assessment method [1]
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Number of participants with angiographic assessment of "complete obliteration".
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Timepoint [1]
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Reintervention or 12 months
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Secondary outcome [2]
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Neurological Assessments
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Assessment method [2]
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The changes in modified Rankin Scores from pre-procedure to 12-month were measured. the outcome below reflects "same or better".
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Timepoint [2]
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12 months
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Secondary outcome [3]
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Technical Procedure Success
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Assessment method [3]
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Timepoint [3]
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Post-procedure
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Secondary outcome [4]
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Target Aneurysm Recurrence
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Assessment method [4]
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Timepoint [4]
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2 years
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Secondary outcome [5]
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Target Aneurysm Recurrence
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Assessment method [5]
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Timepoint [5]
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3 years
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Secondary outcome [6]
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Target Aneurysm Recurrence
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Assessment method [6]
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Timepoint [6]
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5 years
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Eligibility
Key inclusion criteria
1. Patient is between 18 and 80 years of age (inclusive).
2. Patient has a documented untreated intracranial saccular aneurysm 4-20 mm diameter
angiographic lumen, ruptured or unruptured, suitable for embolization with coils.
3. 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).
4. 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.
5. 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.
6. Patient (or patient's legally authorized representative for centers in the United
States) has provided written informed consent.
7. Patient is willing and able to comply with protocol follow-up requirements.
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Minimum age
18
Years
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patient is < 18 or > 80 years old.
2. Target aneurysm is not saccular in nature (mycotic, fusiform, dissecting).
3. Target aneurysm is > 20 mm maximum luminal dimension, < 4 mm maximum luminal
dimension.
4. Target aneurysm has been previously treated by surgery or endovascular therapy.
5. Target aneurysm is in the physician's estimation unlikely to be successfully treated
by endovascular techniques.
6. Patient presents as Hunt and Hess grade IV or V for a ruptured aneurysm.
7. Patient presents with Modified Rankin Score 4 or 5 at baseline.
8. Patient is concurrently enrolled in another investigational drug or device study
unless permission is granted by the sponsor.
9. 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.
10. Patients who have had or could have a severe reaction to contrast agents that cannot
be adequately pre-medicated prior to the coiling procedure.
11. 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.
12. Planned use of adjunctive therapy stents except Neuroform is not allowed.
13. 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.
14. Patients with multiple aneurysms.
15. Target aneurysm with significant thrombosis that may increase the likelihood of
recanalization at the discretion of the investigator.
16. Female patient has a positive pregnancy assessment at baseline.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2015
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Sample size
Target
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Accrual to date
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Final
626
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Recruitment outside Australia
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United States of America
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Arizona
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Augsburg
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Freiburg
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Homburg/Saar
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Mexico City
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Norway
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Oslo
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Alicante
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Spain
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Barcelona
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Madrid
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Spain
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San Sebastian
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Turkey
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Istanbul
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United Kingdom
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Liverpool
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United Kingdom
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Tyne and Wear
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Stryker Neurovascular
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Address
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Ethics approval
Ethics application status
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Summary
Brief 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.
- 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00396981
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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S. Claiborne Johnston, MD, PhD
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Address
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University of California, San Francisco, CA
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00396981
Download to PDF