Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
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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
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
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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  
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
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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 ]

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

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


  Serious Adverse Events
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Additional Description 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


Serious Adverse Events
    Matrix 2® Coils for Endovascular Aneurysm Occlusion     GDC® Coils for Endovascular Aneurysm Occlusion  
Total, serious adverse events      
# participants affected / at risk     85/311 (27.33%)     80/315 (25.40%)  
Blood and lymphatic system disorders      
Haemorrhagic anaemia      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Thrombocytopenia      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Total      
# participants affected / at risk     2/311 (0.64%)     0/315 (0.00%)  
# events     2     0  
Cardiac disorders      
Angina pectoris      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Arrhythmia      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Atrial fibrillation      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Atrioventricular block second degree      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Bradycardia      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Cardiac failure      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Cardiac failure congestive      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Cardiac valve disease      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Cardiovascular disorder      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Myocardial infarction      
# participants affected / at risk     2/311 (0.64%)     0/315 (0.00%)  
# events     2     0  
Total      
# participants affected / at risk     7/311 (2.25%)     5/315 (1.59%)  
# events     8     5  
Ear and labyrinth disorders      
Vertigo      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Eye disorders      
Vision blurred      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Total      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Gastrointestinal disorders      
Diverticular perforation      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Gastrointestinal fistula      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Gastrointestinal haemorrhage      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Intestinal ischaemia      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Oesophagitis      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Peritonitis      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Retroperitoneal haemorrhage      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     3/311 (0.96%)     4/315 (1.27%)  
# events     3     4  
General disorders      
Catheter site discharge      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Catheter site haematoma      
# participants affected / at risk     2/311 (0.64%)     2/315 (0.63%)  
# events     2     2  
Catheter site haemorrhage      
# participants affected / at risk     2/311 (0.64%)     0/315 (0.00%)  
# events     2     0  
Death      
# participants affected / at risk     3/311 (0.96%)     0/315 (0.00%)  
# events     3     0  
Multi-organ failure      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Total      
# participants affected / at risk     8/311 (2.57%)     3/315 (0.95%)  
# events     8     3  
Hepatobiliary disorders      
Chronic hepatic failure      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Immune system disorders      
Drug hypersensitivity      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Infections and infestations      
Arthritis bacterial      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Central nervous system infection      
# participants affected / at risk     2/311 (0.64%)     0/315 (0.00%)  
# events     2     0  
Clostridial infection      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     2     0  
Herpes zoster      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Meningitis      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Pneumonia      
# participants affected / at risk     3/311 (0.96%)     2/315 (0.63%)  
# events     3     2  
Pneumonia escherichia      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Sepsis      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Staphylococcal infection      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Urinary tract infection      
# participants affected / at risk     3/311 (0.96%)     0/315 (0.00%)  
# events     3     0  
Wound infection      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Total      
# participants affected / at risk     11/311 (3.54%)     5/315 (1.59%)  
# events     14     5  
Injury, poisoning and procedural complications      
Brain herniation      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Subdural haematoma      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Total      
# participants affected / at risk     2/311 (0.64%)     1/315 (0.32%)  
# events     2     1  
Investigations      
Blood pressure increased      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Sputum culture positive      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Total      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Metabolism and nutrition disorders      
Dehydration      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Fluid overload      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Total      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Musculoskeletal and connective tissue disorders      
Rhabdomyolysis      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Benign cardiac neoplasm      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Metastases to central nervous system      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Pancreatic carcinoma      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Rectal cancer      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Total      
# participants affected / at risk     2/311 (0.64%)     2/315 (0.63%)  
# events     2     2  
Nervous system disorders      
Autonomic nervous system imbalance      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Basilar artery thrombosis      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Brain oedema      
# participants affected / at risk     2/311 (0.64%)     1/315 (0.32%)  
# events     2     1  
Carotid arterial embolus      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Carotid artery dissection      
# participants affected / at risk     2/311 (0.64%)     2/315 (0.63%)  
# events     2     2  
Carotid artery thrombosis      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Cerebral artery embolism      
# participants affected / at risk     1/311 (0.32%)     2/315 (0.63%)  
# events     1     2  
Cerebral artery thrombosis      
# participants affected / at risk     9/311 (2.89%)     8/315 (2.54%)  
# events     9     8  
Cerebrovascular accident      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Diplegia      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Embolic stroke      
# participants affected / at risk     1/311 (0.32%)     2/315 (0.63%)  
# events     1     2  
Encephalopathy      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Haemorrhagic stroke      
# participants affected / at risk     3/311 (0.96%)     3/315 (0.95%)  
# events     3     3  
Headache      
# participants affected / at risk     2/311 (0.64%)     6/315 (1.90%)  
# events     2     6  
Hemiparesis      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Hydrocephalus      
# participants affected / at risk     3/311 (0.96%)     6/315 (1.90%)  
# events     3     6  
IIIrd nerve disorder      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Intracranial aneurysm      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Intracranial pressure increased      
# participants affected / at risk     1/311 (0.32%)     4/315 (1.27%)  
# events     1     4  
Ischaemic neuropathy      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Ischaemic stroke      
# participants affected / at risk     16/311 (5.14%)     14/315 (4.44%)  
# events     16     15  
Lethargy      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Loss of consciousness      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Memory impairment      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Nervous system disorder      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Neurological symptom      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Paralysis      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Ruptured cerebral aneurysm      
# participants affected / at risk     8/311 (2.57%)     9/315 (2.86%)  
# events     8     9  
Subarachnoid haemorrhage      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Transient ischaemic attack      
# participants affected / at risk     4/311 (1.29%)     3/315 (0.95%)  
# events     4     3  
Total      
# participants affected / at risk     52/311 (16.72%)     53/315 (16.83%)  
# events     64     69  
Psychiatric disorders      
Confusional state      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Total      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Renal and urinary disorders      
Renal failure      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Reproductive system and breast disorders      
Cervical dysplasia      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Total      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Respiratory, thoracic and mediastinal disorders      
Acute respiratory failure      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Atelectasis      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Chronic obstructive pulmonary disease      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Cryptogenic organising pneumonia      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Epistaxis      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Hypoxia      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Laryngospasm      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Pneumonia aspiration      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Pulmonary embolism      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Pulmonary oedema      
# participants affected / at risk     2/311 (0.64%)     0/315 (0.00%)  
# events     2     0  
Respiratory distress      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Respiratory failure      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Total      
# participants affected / at risk     6/311 (1.93%)     6/315 (1.90%)  
# events     8     6  
Vascular disorders      
Artery dissection      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Deep vein thrombosis      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Femoral artery aneurysm      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Femoral artery occlusion      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Iliac artery stenosis      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Peripheral vascular disorder      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Thrombophlebitis superficial      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Vascular pseudoaneurysm      
# participants affected / at risk     2/311 (0.64%)     1/315 (0.32%)  
# events     2     1  
Vasospasm      
# participants affected / at risk     18/311 (5.79%)     20/315 (6.35%)  
# events     19     29  
Venous thrombosis limb      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Vessel perforation      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Total      
# participants affected / at risk     24/311 (7.72%)     24/315 (7.62%)  
# events     27     34  




  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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