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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Timepoint [1] 0 0
Reintervention or 12 months
Secondary outcome [2] 0 0
Neurological Assessments
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
Sex
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
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
626
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
China
State/province [23] 0 0
Beijing
Country [24] 0 0
France
State/province [24] 0 0
Montpellier
Country [25] 0 0
Germany
State/province [25] 0 0
Augsburg
Country [26] 0 0
Germany
State/province [26] 0 0
Freiburg
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Homburg/Saar
Country [29] 0 0
Mexico
State/province [29] 0 0
Mexico City
Country [30] 0 0
Norway
State/province [30] 0 0
Oslo
Country [31] 0 0
Spain
State/province [31] 0 0
Alicante
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Spain
State/province [34] 0 0
San Sebastian
Country [35] 0 0
Turkey
State/province [35] 0 0
Istanbul
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Liverpool
Country [37] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00396981