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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
A Prospective, Randomized, Multicenter Trial Investigating Matrix 2® and GDC® Detachable Coils for the Treatment of Intracranial Saccular Aneurysms
Secondary ID [1] 0 0
BSC0015
Secondary ID [2] 0 0
T4902
Universal Trial Number (UTN)
Trial acronym
MAPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intracranial Aneurysms 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause.
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Angiographic Assessments - Number of participants with angiographic assessment of "complete obliteration".
Timepoint [1] 0 0
Reintervention or 12 months
Secondary outcome [2] 0 0
Neurological Assessments - The changes in modified Rankin Scores from pre-procedure to 12-month were measured. the outcome below reflects "same or better".
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Technical Procedure Success
Timepoint [3] 0 0
Post-procedure
Secondary outcome [4] 0 0
Target Aneurysm Recurrence
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Target Aneurysm Recurrence
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
Target Aneurysm Recurrence
Timepoint [6] 0 0
5 years

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.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
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United States of America
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Arizona
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Connecticut
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Illinois
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Iowa
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nevada
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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South Carolina
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Tennessee
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Texas
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Washington
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United States of America
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Wisconsin
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Canada
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Quebec
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China
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Beijing
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France
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Montpellier
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Germany
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Augsburg
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Homburg/Saar
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Mexico
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Mexico City
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Norway
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Oslo
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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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
State/province [37] 0 0
Tyne and Wear

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Stryker Neurovascular
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00396981
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
S. Claiborne Johnston, MD, PhD
Address 0 0
University of California, San Francisco, CA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications