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MAPS Trial: Matrix And Platinum Science (MAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00396981
Recruitment Status : Completed
First Posted : November 8, 2006
Results First Posted : March 18, 2014
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Intracranial Aneurysms
Interventions Device: Matrix 2® coils for endovascular aneurysm occlusion
Device: GDC® coils for endovascular aneurysm occlusion
Enrollment 626
Recruitment Details 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  
Arm/Group Title Matrix 2® Coils for Endovascular Aneurysm Occlusion GDC® Coils for Endovascular Aneurysm Occlusion
Hide Arm/Group Description

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 : endovascular aneurysm occlusion coil

Period Title: Overall Study
Started 311 315
Completed 296 306
Not Completed 15 9
Arm/Group Title Matrix 2® Coils for Endovascular Aneurysm Occlusion GDC® Coils for Endovascular Aneurysm Occlusion Total
Hide Arm/Group Description

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 : endovascular aneurysm occlusion coil

Total of all reporting groups
Overall Number of Baseline Participants 311 315 626
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 311 participants 315 participants 626 participants
55.7  (11.6) 54.4  (13.2) 55.0  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 311 participants 315 participants 626 participants
Female
229
  73.6%
211
  67.0%
440
  70.3%
Male
82
  26.4%
104
  33.0%
186
  29.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 311 participants 315 participants 626 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
1.Primary Outcome
Title Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause.
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
A totoal of 630 subjects were planned for the study. All enrolled MAPS trial subjects' data is included in the ITT anaylsis except for four subjects who were excluded due to the following reasons: one subject did not have an aneurysm and three subjects', a the request of the IRB, due to non GCP compliance in obtaining the inofrmed consent.
Arm/Group Title Matrix Coils GDC Coils
Hide Arm/Group Description:
Matrix 2® Coils for endovascular aneurysm occlusion
GDC® Coils for endovascular aneurysm occlusion
Overall Number of Participants Analyzed 311 315
Measure Type: Number
Unit of Measure: participants
34 35
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matrix Coils
Comments Intent-to-Treat, All Subjects (N=626) GDC (N=315) Matrix (N=311) All Subjects (N=626) Subjects Who Met Primary Endpoint 35 (11.1%) 34 (10.9%) 69 (11.0%)
Type of Statistical Test Non-Inferiority or Equivalence
Comments This study used a non-inferiority design to demonstrate that the Matrix Coil is non-inferior to the GDC Coil, with a clinically acceptable non-inferiority margin set at 10%. Non-inferiority was used to establish the baseline estimate, which future superiority studies could be conducted. Non-inferiority was shown with a one-sided 95% CI of the difference less than the pre-specified 10% margin
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Angiographic Assessments
Hide Description Number of participants with angiographic assessment of "complete obliteration".
Time Frame Reintervention or 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matrix Coils GDC Coils
Hide Arm/Group Description:
Matrix 2® Coils for endovascular aneurysm occlusion
GDC® Coils for endovascular aneurysm occlusion
Overall Number of Participants Analyzed 238 250
Measure Type: Number
Unit of Measure: participants
87 89
3.Secondary Outcome
Title Neurological Assessments
Hide Description The changes in modified Rankin Scores from pre-procedure to 12-month were measured. the outcome below reflects "same or better".
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matrix Coils GDC Coils
Hide Arm/Group Description:
Matrix 2® Coils for endovascular aneurysm occlusion
GDC® Coils for endovascular aneurysm occlusion
Overall Number of Participants Analyzed 311 315
Measure Type: Number
Unit of Measure: percentage of participants
90.1 88.3
4.Secondary Outcome
Title Technical Procedure Success
Hide Description [Not Specified]
Time Frame Post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matrix Coils GDC Coils
Hide Arm/Group Description:
Matrix 2® Coils for endovascular aneurysm occlusion
GDC® Coils for endovascular aneurysm occlusion
Overall Number of Participants Analyzed 311 315
Measure Type: Number
Unit of Measure: percentage of participants
96.8 97.5
5.Secondary Outcome
Title Target Aneurysm Recurrence
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matrix Coils GDC Coils
Hide Arm/Group Description:
Matrix 2® Coils for endovascular aneurysm occlusion
GDC® Coils for endovascular aneurysm occlusion
Overall Number of Participants Analyzed 311 315
Measure Type: Number
Unit of Measure: participants
42 42
6.Secondary Outcome
Title Target Aneurysm Recurrence
Hide Description [Not Specified]
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matrix Coils GDC Coils
Hide Arm/Group Description:
Matrix 2® Coils for endovascular aneurysm occlusion
GDC® Coils for endovascular aneurysm occlusion
Overall Number of Participants Analyzed 311 315
Measure Type: Number
Unit of Measure: participants
43 45
7.Secondary Outcome
Title Target Aneurysm Recurrence
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matrix Coils GDC Coils
Hide Arm/Group Description:
Matrix 2® Coils for endovascular aneurysm occlusion
GDC® Coils for endovascular aneurysm occlusion
Overall Number of Participants Analyzed 311 315
Measure Type: Number
Unit of Measure: participants
44 46
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Matrix Coils GDC Coils
Hide Arm/Group Description Matrix 2® Coils for endovascular aneurysm occlusion GDC® Coils for endovascular aneurysm occlusion
All-Cause Mortality
Matrix Coils GDC Coils
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Matrix Coils GDC Coils
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   85/311 (27.33%)      80/315 (25.40%)    
Blood and lymphatic system disorders     
Haemorrhagic anaemia   1/311 (0.32%)  1 0/315 (0.00%)  0
Thrombocytopenia   1/311 (0.32%)  1 0/315 (0.00%)  0
Total   2/311 (0.64%)  2 0/315 (0.00%)  0
Cardiac disorders     
Angina pectoris   1/311 (0.32%)  1 0/315 (0.00%)  0
Arrhythmia   0/311 (0.00%)  0 1/315 (0.32%)  1
Atrial fibrillation   1/311 (0.32%)  1 1/315 (0.32%)  1
Atrioventricular block second degree   0/311 (0.00%)  0 1/315 (0.32%)  1
Bradycardia   1/311 (0.32%)  1 1/315 (0.32%)  1
Cardiac failure   0/311 (0.00%)  0 1/315 (0.32%)  1
Cardiac failure congestive   1/311 (0.32%)  1 0/315 (0.00%)  0
Cardiac valve disease   1/311 (0.32%)  1 0/315 (0.00%)  0
Cardiovascular disorder   1/311 (0.32%)  1 0/315 (0.00%)  0
Myocardial infarction   2/311 (0.64%)  2 0/315 (0.00%)  0
Total   7/311 (2.25%)  8 5/315 (1.59%)  5
Ear and labyrinth disorders     
Vertigo   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   0/311 (0.00%)  0 1/315 (0.32%)  1
Eye disorders     
Vision blurred   1/311 (0.32%)  1 0/315 (0.00%)  0
Total   1/311 (0.32%)  1 0/315 (0.00%)  0
Gastrointestinal disorders     
Diverticular perforation   1/311 (0.32%)  1 0/315 (0.00%)  0
Gastrointestinal fistula   0/311 (0.00%)  0 1/315 (0.32%)  1
Gastrointestinal haemorrhage   1/311 (0.32%)  1 0/315 (0.00%)  0
Intestinal ischaemia   1/311 (0.32%)  1 0/315 (0.00%)  0
Oesophagitis   0/311 (0.00%)  0 1/315 (0.32%)  1
Peritonitis   0/311 (0.00%)  0 1/315 (0.32%)  1
Retroperitoneal haemorrhage   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   3/311 (0.96%)  3 4/315 (1.27%)  4
General disorders     
Catheter site discharge   0/311 (0.00%)  0 1/315 (0.32%)  1
Catheter site haematoma   2/311 (0.64%)  2 2/315 (0.63%)  2
Catheter site haemorrhage   2/311 (0.64%)  2 0/315 (0.00%)  0
Death   3/311 (0.96%)  3 0/315 (0.00%)  0
Multi-organ failure   1/311 (0.32%)  1 0/315 (0.00%)  0
Total   8/311 (2.57%)  8 3/315 (0.95%)  3
Hepatobiliary disorders     
Chronic hepatic failure   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   0/311 (0.00%)  0 1/315 (0.32%)  1
Immune system disorders     
Drug hypersensitivity   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   0/311 (0.00%)  0 1/315 (0.32%)  1
Infections and infestations     
Arthritis bacterial   0/311 (0.00%)  0 1/315 (0.32%)  1
Central nervous system infection   2/311 (0.64%)  2 0/315 (0.00%)  0
Clostridial infection   1/311 (0.32%)  2 0/315 (0.00%)  0
Herpes zoster   1/311 (0.32%)  1 0/315 (0.00%)  0
Meningitis   0/311 (0.00%)  0 1/315 (0.32%)  1
Pneumonia   3/311 (0.96%)  3 2/315 (0.63%)  2
Pneumonia escherichia   1/311 (0.32%)  1 0/315 (0.00%)  0
Sepsis   0/311 (0.00%)  0 1/315 (0.32%)  1
Staphylococcal infection   1/311 (0.32%)  1 0/315 (0.00%)  0
Urinary tract infection   3/311 (0.96%)  3 0/315 (0.00%)  0
Wound infection   1/311 (0.32%)  1 0/315 (0.00%)  0
Total   11/311 (3.54%)  14 5/315 (1.59%)  5
Injury, poisoning and procedural complications     
Brain herniation   1/311 (0.32%)  1 1/315 (0.32%)  1
Subdural haematoma   1/311 (0.32%)  1 0/315 (0.00%)  0
Total   2/311 (0.64%)  2 1/315 (0.32%)  1
Investigations     
Blood pressure increased   0/311 (0.00%)  0 1/315 (0.32%)  1
Sputum culture positive   1/311 (0.32%)  1 0/315 (0.00%)  0
Total   1/311 (0.32%)  1 1/315 (0.32%)  1
Metabolism and nutrition disorders     
Dehydration   0/311 (0.00%)  0 1/315 (0.32%)  1
Fluid overload   1/311 (0.32%)  1 0/315 (0.00%)  0
Total   1/311 (0.32%)  1 1/315 (0.32%)  1
Musculoskeletal and connective tissue disorders     
Rhabdomyolysis   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   0/311 (0.00%)  0 1/315 (0.32%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign cardiac neoplasm   1/311 (0.32%)  1 0/315 (0.00%)  0
Metastases to central nervous system   0/311 (0.00%)  0 1/315 (0.32%)  1
Pancreatic carcinoma   0/311 (0.00%)  0 1/315 (0.32%)  1
Rectal cancer   1/311 (0.32%)  1 0/315 (0.00%)  0
Total   2/311 (0.64%)  2 2/315 (0.63%)  2
Nervous system disorders     
Autonomic nervous system imbalance   0/311 (0.00%)  0 1/315 (0.32%)  1
Basilar artery thrombosis   1/311 (0.32%)  1 0/315 (0.00%)  0
Brain oedema   2/311 (0.64%)  2 1/315 (0.32%)  1
Carotid arterial embolus   1/311 (0.32%)  1 0/315 (0.00%)  0
Carotid artery dissection   2/311 (0.64%)  2 2/315 (0.63%)  2
Carotid artery thrombosis   1/311 (0.32%)  1 0/315 (0.00%)  0
Cerebral artery embolism   1/311 (0.32%)  1 2/315 (0.63%)  2
Cerebral artery thrombosis   9/311 (2.89%)  9 8/315 (2.54%)  8
Cerebrovascular accident   1/311 (0.32%)  1 1/315 (0.32%)  1
Diplegia   1/311 (0.32%)  1 0/315 (0.00%)  0
Embolic stroke   1/311 (0.32%)  1 2/315 (0.63%)  2
Encephalopathy   1/311 (0.32%)  1 0/315 (0.00%)  0
Haemorrhagic stroke   3/311 (0.96%)  3 3/315 (0.95%)  3
Headache   2/311 (0.64%)  2 6/315 (1.90%)  6
Hemiparesis   0/311 (0.00%)  0 1/315 (0.32%)  1
Hydrocephalus   3/311 (0.96%)  3 6/315 (1.90%)  6
IIIrd nerve disorder   0/311 (0.00%)  0 1/315 (0.32%)  1
Intracranial aneurysm   0/311 (0.00%)  0 1/315 (0.32%)  1
Intracranial pressure increased   1/311 (0.32%)  1 4/315 (1.27%)  4
Ischaemic neuropathy   1/311 (0.32%)  1 0/315 (0.00%)  0
Ischaemic stroke   16/311 (5.14%)  16 14/315 (4.44%)  15
Lethargy   1/311 (0.32%)  1 0/315 (0.00%)  0
Loss of consciousness   1/311 (0.32%)  1 0/315 (0.00%)  0
Memory impairment   0/311 (0.00%)  0 1/315 (0.32%)  1
Nervous system disorder   0/311 (0.00%)  0 1/315 (0.32%)  1
Neurological symptom   1/311 (0.32%)  1 0/315 (0.00%)  0
Paralysis   1/311 (0.32%)  1 0/315 (0.00%)  0
Ruptured cerebral aneurysm   8/311 (2.57%)  8 9/315 (2.86%)  9
Subarachnoid haemorrhage   1/311 (0.32%)  1 1/315 (0.32%)  1
Transient ischaemic attack   4/311 (1.29%)  4 3/315 (0.95%)  3
Total   52/311 (16.72%)  64 53/315 (16.83%)  69
Psychiatric disorders     
Confusional state   1/311 (0.32%)  1 0/315 (0.00%)  0
Total   1/311 (0.32%)  1 0/315 (0.00%)  0
Renal and urinary disorders     
Renal failure   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   0/311 (0.00%)  0 1/315 (0.32%)  1
Reproductive system and breast disorders     
Cervical dysplasia   1/311 (0.32%)  1 0/315 (0.00%)  0
Total   1/311 (0.32%)  1 0/315 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure   1/311 (0.32%)  1 0/315 (0.00%)  0
Atelectasis   0/311 (0.00%)  0 1/315 (0.32%)  1
Chronic obstructive pulmonary disease   1/311 (0.32%)  1 0/315 (0.00%)  0
Cryptogenic organising pneumonia   0/311 (0.00%)  0 1/315 (0.32%)  1
Epistaxis   0/311 (0.00%)  0 1/315 (0.32%)  1
Hypoxia   0/311 (0.00%)  0 1/315 (0.32%)  1
Laryngospasm   0/311 (0.00%)  0 1/315 (0.32%)  1
Pneumonia aspiration   1/311 (0.32%)  1 0/315 (0.00%)  0
Pulmonary embolism   1/311 (0.32%)  1 1/315 (0.32%)  1
Pulmonary oedema   2/311 (0.64%)  2 0/315 (0.00%)  0
Respiratory distress   1/311 (0.32%)  1 0/315 (0.00%)  0
Respiratory failure   1/311 (0.32%)  1 0/315 (0.00%)  0
Total   6/311 (1.93%)  8 6/315 (1.90%)  6
Vascular disorders     
Artery dissection   1/311 (0.32%)  1 0/315 (0.00%)  0
Deep vein thrombosis   1/311 (0.32%)  1 0/315 (0.00%)  0
Femoral artery aneurysm   1/311 (0.32%)  1 0/315 (0.00%)  0
Femoral artery occlusion   0/311 (0.00%)  0 1/315 (0.32%)  1
Iliac artery stenosis   0/311 (0.00%)  0 1/315 (0.32%)  1
Peripheral vascular disorder   1/311 (0.32%)  1 0/315 (0.00%)  0
Thrombophlebitis superficial   1/311 (0.32%)  1 0/315 (0.00%)  0
Vascular pseudoaneurysm   2/311 (0.64%)  2 1/315 (0.32%)  1
Vasospasm   18/311 (5.79%)  19 20/315 (6.35%)  29
Venous thrombosis limb   0/311 (0.00%)  0 1/315 (0.32%)  1
Vessel perforation   1/311 (0.32%)  1 1/315 (0.32%)  1
Total   24/311 (7.72%)  27 24/315 (7.62%)  34
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Matrix Coils GDC Coils
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   112/311 (36.01%)      120/315 (38.10%)    
Blood and lymphatic system disorders     
Anaemia   3/311 (0.96%)  3 2/315 (0.63%)  2
Leukocytosis   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   3/311 (0.96%)  3 3/315 (0.95%)  3
Cardiac disorders     
Angina pectoris   1/311 (0.32%)  1 0/315 (0.00%)  0
Arrhythmia supraventricular   0/311 (0.00%)  0 1/315 (0.32%)  1
Atrial fibrillation   0/311 (0.00%)  0 1/315 (0.32%)  1
Bradycardia   1/311 (0.32%)  1 2/315 (0.63%)  2
Cardiac failure congestive   2/311 (0.64%)  2 0/315 (0.00%)  0
Sinus tachycardia   0/311 (0.00%)  0 1/315 (0.32%)  1
Supraventricular tachycardia   1/311 (0.32%)  1 0/315 (0.00%)  0
Tachycardia   3/311 (0.96%)  3 2/315 (0.63%)  2
Total   7/311 (2.25%)  8 7/315 (2.22%)  7
Ear and labyrinth disorders     
Ear pain   0/311 (0.00%)  0 1/315 (0.32%)  1
Tinnitus   1/311 (0.32%)  1 0/315 (0.00%)  0
Vertigo   1/311 (0.32%)  1 0/315 (0.00%)  0
Total   2/311 (0.64%)  2 1/315 (0.32%)  1
Endocrine disorders     
Diabetes insipidus   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   0/311 (0.00%)  0 1/315 (0.32%)  1
Eye disorders     
Blindness unilateral   0/311 (0.00%)  0 1/315 (0.32%)  1
Diplopia   3/311 (0.96%)  3 1/315 (0.32%)  1
Eye pain   1/311 (0.32%)  1 2/315 (0.63%)  2
Eye swelling   1/311 (0.32%)  1 0/315 (0.00%)  0
Macular degeneration   0/311 (0.00%)  0 1/315 (0.32%)  1
Photophobia   1/311 (0.32%)  1 0/315 (0.00%)  0
Photopsia   1/311 (0.32%)  1 0/315 (0.00%)  0
Retinal artery occlusion   0/311 (0.00%)  0 1/315 (0.32%)  1
Retinal haemorrhage   1/311 (0.32%)  1 0/315 (0.00%)  0
Strabismus   1/311 (0.32%)  1 0/315 (0.00%)  0
Vision blurred   3/311 (0.96%)  3 4/315 (1.27%)  4
Visual disturbance   1/311 (0.32%)  1 5/315 (1.59%)  5
Vitreous floaters   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   10/311 (3.22%)  13 15/315 (4.76%)  16
Gastrointestinal disorders     
Abdominal pain   1/311 (0.32%)  1 0/315 (0.00%)  0
Abdominal pain upper   0/311 (0.00%)  0 1/315 (0.32%)  1
Constipation   1/311 (0.32%)  1 0/315 (0.00%)  0
Diarrhoea   3/311 (0.96%)  3 0/315 (0.00%)  0
Gastritis   1/311 (0.32%)  1 0/315 (0.00%)  0
Hernial eventration   0/311 (0.00%)  0 1/315 (0.32%)  1
Nausea   10/311 (3.22%)  10 10/315 (3.17%)  10
Tongue disorder   0/311 (0.00%)  0 1/315 (0.32%)  1
Vomiting   4/311 (1.29%)  4 3/315 (0.95%)  3
Total   14/311 (4.50%)  20 13/315 (4.13%)  16
General disorders     
Adverse drug reaction   2/311 (0.64%)  2 0/315 (0.00%)  0
Asthenia   0/311 (0.00%)  0 1/315 (0.32%)  1
Catheter site discharge   6/311 (1.93%)  6 10/315 (3.17%)  10
Catheter site haematoma   12/311 (3.86%)  12 16/315 (5.08%)  16
Catheter site haemorrhage   4/311 (1.29%)  4 3/315 (0.95%)  3
Catheter site pain   8/311 (2.57%)  8 6/315 (1.90%)  6
Catheter site rash   1/311 (0.32%)  1 0/315 (0.00%)  0
Chest pain   1/311 (0.32%)  1 2/315 (0.63%)  2
Fatigue   1/311 (0.32%)  1 0/315 (0.00%)  0
Hyperthermia   1/311 (0.32%)  1 0/315 (0.00%)  0
Infusion site extravasation   1/311 (0.32%)  1 0/315 (0.00%)  0
Oedema peripheral   1/311 (0.32%)  1 0/315 (0.00%)  0
Peripheral coldness   1/311 (0.32%)  1 0/315 (0.00%)  0
Pyrexia   4/311 (1.29%)  4 2/315 (0.63%)  2
Total   33/311 (10.61%)  43 31/315 (9.84%)  40
Immune system disorders     
Contrast media allergy   0/311 (0.00%)  0 1/315 (0.32%)  1
Drug hypersensitivity   0/311 (0.00%)  0 1/315 (0.32%)  1
Hypersensitivity   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   0/311 (0.00%)  0 3/315 (0.95%)  3
Infections and infestations     
Bacteraemia   1/311 (0.32%)  1 0/315 (0.00%)  0
Catheter site infection   0/311 (0.00%)  0 1/315 (0.32%)  1
Clostridium difficile colitis   1/311 (0.32%)  1 0/315 (0.00%)  0
Ear infection   1/311 (0.32%)  1 0/315 (0.00%)  0
Hepatitis E   1/311 (0.32%)  1 0/315 (0.00%)  0
Infusion site infection   1/311 (0.32%)  1 0/315 (0.00%)  0
Lung infection   1/311 (0.32%)  1 2/315 (0.63%)  2
Meningitis   1/311 (0.32%)  1 0/315 (0.00%)  0
Nasopharyngitis   1/311 (0.32%)  1 1/315 (0.32%)  1
Oral candidiasis   1/311 (0.32%)  1 0/315 (0.00%)  0
Pneumonia   5/311 (1.61%)  5 1/315 (0.32%)  1
Respiratory tract infection   1/311 (0.32%)  1 1/315 (0.32%)  1
Tracheitis   0/311 (0.00%)  0 1/315 (0.32%)  1
Upper respiratory tract infection   1/311 (0.32%)  1 0/315 (0.00%)  0
Upper respiratory tract infection bact   0/311 (0.00%)  0 1/315 (0.32%)  1
Urinary tract infection   8/311 (2.57%)  9 9/315 (2.86%)  9
Viral infection   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   21/311 (6.75%)  25 15/315 (4.76%)  18
Injury, poisoning and procedural complications     
Ankle fracture   0/311 (0.00%)  0 1/315 (0.32%)  1
Contusion   2/311 (0.64%)  2 1/315 (0.32%)  1
Patella fracture   0/311 (0.00%)  0 1/315 (0.32%)  1
Procedural hypertension   1/311 (0.32%)  1 4/315 (1.27%)  4
Procedural hypotension   1/311 (0.32%)  1 0/315 (0.00%)  0
Procedural nausea   0/311 (0.00%)  0 1/315 (0.32%)  1
Radiation skin injury   0/311 (0.00%)  0 1/315 (0.32%)  1
Scratch   0/311 (0.00%)  0 1/315 (0.32%)  1
Skeletal injury   1/311 (0.32%)  1 0/315 (0.00%)  0
Total   5/311 (1.61%)  5 10/315 (3.17%)  10
Investigations     
Electrocardiogram ST segment abnormal   1/311 (0.32%)  1 0/315 (0.00%)  0
Troponin increased   0/311 (0.00%)  0 1/315 (0.32%)  1
Ultrasound Doppler abnormal   0/311 (0.00%)  0 1/315 (0.32%)  1
Urine sodium increased   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   1/311 (0.32%)  1 3/315 (0.95%)  3
Metabolism and nutrition disorders     
Dehydration   0/311 (0.00%)  0 1/315 (0.32%)  1
Electrolyte imbalance   1/311 (0.32%)  1 2/315 (0.63%)  2
Fluid overload   0/311 (0.00%)  0 1/315 (0.32%)  1
Hyperchloraemia   1/311 (0.32%)  1 0/315 (0.00%)  0
Hyperglycaemia   0/311 (0.00%)  0 1/315 (0.32%)  1
Hyperkalaemia   1/311 (0.32%)  1 0/315 (0.00%)  0
Hypermagnesaemia   1/311 (0.32%)  1 2/315 (0.63%)  2
Hypocalcaemia   1/311 (0.32%)  1 1/315 (0.32%)  1
Hypokalaemia   1/311 (0.32%)  1 2/315 (0.63%)  2
Hyponatraemia   4/311 (1.29%)  4 2/315 (0.63%)  2
Hypophosphataemia   1/311 (0.32%)  1 1/315 (0.32%)  1
Metabolic disorder   1/311 (0.32%)  1 0/315 (0.00%)  0
Total   7/311 (2.25%)  12 7/315 (2.22%)  13
Musculoskeletal and connective tissue disorders     
Arthralgia   0/311 (0.00%)  0 1/315 (0.32%)  1
Back pain   3/311 (0.96%)  3 3/315 (0.95%)  3
Fibromyalgia   0/311 (0.00%)  0 1/315 (0.32%)  1
Muscle spasms   0/311 (0.00%)  0 1/315 (0.32%)  1
Muscle twitching   1/311 (0.32%)  1 0/315 (0.00%)  0
Musculoskeletal pain   2/311 (0.64%)  2 0/315 (0.00%)  0
Musculoskeletal stiffness   0/311 (0.00%)  0 1/315 (0.32%)  1
Neck pain   0/311 (0.00%)  0 1/315 (0.32%)  1
Osteoporotic fracture   0/311 (0.00%)  0 1/315 (0.32%)  1
Pain in extremity   0/311 (0.00%)  0 4/315 (1.27%)  4
Pain in jaw   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   5/311 (1.61%)  6 13/315 (4.13%)  14
Nervous system disorders     
Balance disorder   2/311 (0.64%)  2 1/315 (0.32%)  1
Brain oedema   0/311 (0.00%)  0 1/315 (0.32%)  1
CNS ventriculitis   0/311 (0.00%)  0 1/315 (0.32%)  1
Carotid artery dissection   1/311 (0.32%)  1 1/315 (0.32%)  1
Carotid artery thrombosis   0/311 (0.00%)  0 1/315 (0.32%)  1
Cerebral artery embolism   1/311 (0.32%)  1 0/315 (0.00%)  0
Cerebral artery occlusion   1/311 (0.32%)  1 0/315 (0.00%)  0
Cerebral artery stenosis   1/311 (0.32%)  1 0/315 (0.00%)  0
Cerebral artery thrombosis   7/311 (2.25%)  7 2/315 (0.63%)  2
Convulsion   0/311 (0.00%)  0 2/315 (0.63%)  2
Coordination abnormal   0/311 (0.00%)  0 1/315 (0.32%)  1
Dizziness   3/311 (0.96%)  3 1/315 (0.32%)  1
Embolic stroke   0/311 (0.00%)  0 1/315 (0.32%)  1
Headache   54/311 (17.36%)  59 57/315 (18.10%)  68
Hydrocephalus   0/311 (0.00%)  0 1/315 (0.32%)  1
Hypoaesthesia   0/311 (0.00%)  0 3/315 (0.95%)  3
Intracranial aneurysm   2/311 (0.64%)  2 0/315 (0.00%)  0
Intracranial pressure increased   0/311 (0.00%)  0 1/315 (0.32%)  1
Ischaemic stroke   3/311 (0.96%)  3 3/315 (0.95%)  3
Lethargy   1/311 (0.32%)  1 0/315 (0.00%)  0
Memory impairment   0/311 (0.00%)  0 1/315 (0.32%)  1
Migraine   1/311 (0.32%)  1 1/315 (0.32%)  1
Paraesthesia   1/311 (0.32%)  1 0/315 (0.00%)  0
Peroneal nerve palsy   0/311 (0.00%)  0 1/315 (0.32%)  1
Ruptured cerebral aneurysm   1/311 (0.32%)  1 1/315 (0.32%)  1
Sciatica   0/311 (0.00%)  0 1/315 (0.32%)  1
Sensory loss   0/311 (0.00%)  0 1/315 (0.32%)  1
Syncope   1/311 (0.32%)  1 0/315 (0.00%)  0
Transient ischaemic attack   2/311 (0.64%)  2 4/315 (1.27%)  5
Tremor   2/311 (0.64%)  2 0/315 (0.00%)  0
VIth nerve paralysis   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   73/311 (23.47%)  89 78/315 (24.76%)  100
Psychiatric disorders     
Alcohol withdrawal syndrome   1/311 (0.32%)  1 0/315 (0.00%)  0
Anxiety   0/311 (0.00%)  0 1/315 (0.32%)  1
Confusional state   1/311 (0.32%)  1 1/315 (0.32%)  1
Delirium   1/311 (0.32%)  1 0/315 (0.00%)  0
Depression   1/311 (0.32%)  1 0/315 (0.00%)  0
Insomnia   2/311 (0.64%)  2 0/315 (0.00%)  0
Mental status changes   1/311 (0.32%)  1 1/315 (0.32%)  1
Sleep disorder   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   7/311 (2.25%)  7 4/315 (1.27%)  4
Renal and urinary disorders     
Renal failure   0/311 (0.00%)  0 1/315 (0.32%)  1
Urethral haemorrhage   0/311 (0.00%)  0 2/315 (0.63%)  2
Urinary retention   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   0/311 (0.00%)  0 4/315 (1.27%)  4
Respiratory, thoracic and mediastinal disorders     
Aspiration   0/311 (0.00%)  0 1/315 (0.32%)  1
Dyspnoea   2/311 (0.64%)  2 2/315 (0.63%)  2
Epistaxis   5/311 (1.61%)  5 2/315 (0.63%)  2
Haemoptysis   1/311 (0.32%)  1 1/315 (0.32%)  1
Pharyngolaryngeal pain   0/311 (0.00%)  0 1/315 (0.32%)  1
Pneumonia aspiration   0/311 (0.00%)  0 1/315 (0.32%)  1
Total   8/311 (2.57%)  8 7/315 (2.22%)  8
Skin and subcutaneous tissue disorders     
Alopecia   4/311 (1.29%)  4 4/315 (1.27%)  4
Ecchymosis   0/311 (0.00%)  0 1/315 (0.32%)  1
Increased tendency to bruise   1/311 (0.32%)  1 0/315 (0.00%)  0
Rash   0/311 (0.00%)  0 2/315 (0.63%)  2
Rash generalised   0/311 (0.00%)  0 1/315 (0.32%)  1
Swelling face   0/311 (0.00%)  0 1/315 (0.32%)  1
Urticaria   1/311 (0.32%)  1 0/315 (0.00%)  0
Total   6/311 (1.93%)  6 9/315 (2.86%)  9
Vascular disorders     
Artery dissection   1/311 (0.32%)  1 1/315 (0.32%)  1
Blood pressure fluctuation   0/311 (0.00%)  0 1/315 (0.32%)  1
Hot flush   1/311 (0.32%)  1 0/315 (0.00%)  0
Hypertension   3/311 (0.96%)  3 0/315 (0.00%)  0
Hypotension   6/311 (1.93%)  6 7/315 (2.22%)  7
Intermittent claudication   1/311 (0.32%)  1 0/315 (0.00%)  0
Peripheral artery aneurysm   1/311 (0.32%)  1 0/315 (0.00%)  0
Phlebitis   1/311 (0.32%)  1 0/315 (0.00%)  0
Vasospasm   9/311 (2.89%)  9 8/315 (2.54%)  8
Total   23/311 (7.40%)  23 17/315 (5.40%)  17
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: S. Claiboren Johnston, MD, PhD
Organization: University of California, UCSF Medical Center
Phone: 415-502-7487
EMail: Clay.Johnston@ucsfmedctr.org
Layout table for additonal information
Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT00396981    
Other Study ID Numbers: T4902
BSC0015 ( Other Identifier: Stryker Neurovascular )
First Submitted: November 6, 2006
First Posted: November 8, 2006
Results First Submitted: February 7, 2013
Results First Posted: March 18, 2014
Last Update Posted: February 17, 2016