MAPS Trial: Matrix And Platinum Science

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT00396981
First received: November 6, 2006
Last updated: March 17, 2014
Last verified: February 2013
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
  Hide Participant Flow

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
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


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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Show All Outcome Measures

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 ]

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: S. Claiboren Johnston, MD, PhD
Organization: University of California, UCSF Medical Center
phone: 415-502-7487
e-mail: Clay.Johnston@ucsfmedctr.org


No publications provided by Stryker Neurovascular

Publications automatically indexed to this study:

Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT00396981     History of Changes
Other Study ID Numbers: T4902, BSC0015
Study First Received: November 6, 2006
Results First Received: February 7, 2013
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board