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MAPS Trial: Matrix And Platinum Science (MAPS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT00396981
First received: November 6, 2006
Last updated: January 19, 2016
Last verified: January 2016
Results First Received: February 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Intracranial Aneurysms
Interventions: Device: Matrix 2® coils for endovascular aneurysm occlusion
Device: GDC® coils for endovascular aneurysm occlusion

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment in the study occurred over 31 months at 26 sites in the US and 17 International. Each site was allowed to enroll up to 60 consecutive subjects; recruitment for the study was competitive. The first subject was enrolled on 29 March 2007 and the enrollment completed on 21 October 2009. A total of 626 subjects were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Matrix 2® Coils for Endovascular Aneurysm Occlusion

Matrix 2® Coils for endovascular aneurysm occlusion

Matrix 2® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil

GDC® Coils for Endovascular Aneurysm Occlusion

GDC® Coils for endovascular aneurysm occlusion

GDC® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil


Participant Flow:   Overall Study
    Matrix 2® Coils for Endovascular Aneurysm Occlusion   GDC® Coils for Endovascular Aneurysm Occlusion
STARTED   311   315 
COMPLETED   296   306 
NOT COMPLETED   15   9 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Matrix 2® Coils for Endovascular Aneurysm Occlusion

Matrix 2® Coils for endovascular aneurysm occlusion

Matrix 2® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil

GDC® Coils for Endovascular Aneurysm Occlusion

GDC® Coils for endovascular aneurysm occlusion

GDC® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil

Total Total of all reporting groups

Baseline Measures
   Matrix 2® Coils for Endovascular Aneurysm Occlusion   GDC® Coils for Endovascular Aneurysm Occlusion   Total 
Overall Participants Analyzed 
[Units: Participants]
 311   315   626 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.7  (11.6)   54.4  (13.2)   55.0  (12.5) 
Gender 
[Units: Participants]
     
Female   229   211   440 
Male   82   104   186 
Region of Enrollment 
[Units: Participants]
     
France   17   15   32 
United States   183   190   373 
Mexico   1   2   3 
Canada   16   15   31 
Spain   46   44   90 
Turkey   4   6   10 
Australia   1   3   4 
Norway   6   5   11 
Germany   13   10   23 
China   7   9   16 
United Kingdom   17   16   33 


  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Angiographic Assessments   [ Time Frame: Reintervention or 12 months ]
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Measure Type Secondary
Measure Title Angiographic Assessments
Measure Description Number of participants with angiographic assessment of "complete obliteration".
Time Frame Reintervention or 12 months  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Matrix Coils Matrix 2® Coils for endovascular aneurysm occlusion
GDC Coils GDC® Coils for endovascular aneurysm occlusion

Measured Values
   Matrix Coils   GDC Coils 
Participants Analyzed 
[Units: Participants]
 238   250 
Angiographic Assessments 
[Units: Participants]
 87   89 

No statistical analysis provided for Angiographic Assessments



3.  Secondary:   Neurological Assessments   [ Time Frame: 12 months ]

4.  Secondary:   Technical Procedure Success   [ Time Frame: Post-procedure ]

5.  Secondary:   Target Aneurysm Recurrence   [ Time Frame: 2 years ]

6.  Secondary:   Target Aneurysm Recurrence   [ Time Frame: 3 years ]

7.  Secondary:   Target Aneurysm Recurrence   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information