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Solitaire™ With the Intention For Thrombectomy as PRIMary Endovascular Treatment (SWIFT PRIME) Trial (SWIFT PRIME)

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ClinicalTrials.gov Identifier: NCT01657461
Recruitment Status : Completed
First Posted : August 6, 2012
Results First Posted : May 18, 2017
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Ischemic Stroke
Interventions Drug: Intravenous (IV) recombinant human tissue plasminogen activator (rtPA)
Device: Solitaire revascularization device
Enrollment 196

Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV t-PA With Solitaire™ Revascularization Device IV t-PA
Hide Arm/Group Description Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR IV infusion of tPA
Period Title: Overall Study
Started 98 98
Completed 88 78
Not Completed 10 20
Reason Not Completed
Death             9             12
Lost to Follow-up             0             3
Physician Decision             0             2
Withdrawal by Subject             1             3
Arm/Group Title IV t-PA With Solitaire™ Revascularization Device IV t-PA Total
Hide Arm/Group Description Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR IV infusion of tPA Total of all reporting groups
Overall Number of Baseline Participants 98 96 194
Hide Baseline Analysis Population Description
Two subjects in the IV t-PA arm withdrew and requested all data removed and was not included in analysis.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 95 participants 193 participants
64.99  (12.49) 66.32  (11.277) 65.64  (11.89)
[1]
Measure Analysis Population Description: Date of birth was not recorded per country regulations.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 96 participants 194 participants
Female
44
  44.9%
51
  53.1%
95
  49.0%
Male
54
  55.1%
45
  46.9%
99
  51.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 98 participants 96 participants 194 participants
65 66 131
Austria Number Analyzed 98 participants 96 participants 194 participants
1 1 2
Denmark Number Analyzed 98 participants 96 participants 194 participants
1 1 2
France Number Analyzed 98 participants 96 participants 194 participants
8 4 12
Germany Number Analyzed 98 participants 96 participants 194 participants
20 22 42
Spain Number Analyzed 98 participants 96 participants 194 participants
1 1 2
Switzerland Number Analyzed 98 participants 96 participants 194 participants
2 1 3
NIHSS   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 98 participants 94 participants 192 participants
16.69  (4.68) 16.49  (4.60) 16.59  (4.63)
[1]
Measure Description: The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 – 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.
[2]
Measure Analysis Population Description: Two subjects in the IV t-PA arm did not have baseline NIHSS recorded
1.Primary Outcome
Title 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).
Hide Description

mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. 0 No symptoms at all

  1. No significant disability despite symptoms; able to carry out all usual duties and activities
  2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
  3. Moderate disability; requiring some help, but able to walk without assistance
  4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
  5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention
  6. Dead
Time Frame 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Final assessment unavailable for 5 subjects that withdrew consent or investigator withdrew consent in IV t-PA arm.
Arm/Group Title IV t-PA With Solitaire™ Revascularization Device IV t-PA
Hide Arm/Group Description:
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
IV infusion of tPA
Overall Number of Participants Analyzed 98 93
Measure Type: Count of Participants
Unit of Measure: Participants
mRS 0
17
  17.3%
8
   8.6%
mRS 1
25
  25.5%
10
  10.8%
mRS 2
17
  17.3%
15
  16.1%
mRS 3
12
  12.2%
16
  17.2%
mRS 4
15
  15.3%
20
  21.5%
mRS 5/6
12
  12.2%
24
  25.8%
2.Secondary Outcome
Title Death Due to Any Cause at 90 Days
Hide Description [Not Specified]
Time Frame 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the IV t-PA arm withdrew and requested all data be removed.
Arm/Group Title IV t-PA With Solitaire™ Revascularization Device IV t-PA
Hide Arm/Group Description:
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
IV infusion of tPA
Overall Number of Participants Analyzed 98 97
Measure Type: Count of Participants
Unit of Measure: Participants
9
   9.2%
12
  12.4%
3.Secondary Outcome
Title Functional Independence as Defined by Modified Rankin Scale (mRS) Score ≤2 at 90 Days
Hide Description [Not Specified]
Time Frame 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Final assessment unavailable for 5 subjects that withdrew consent or investigator withdrew consent in IV t-PA arm.
Arm/Group Title IV t-PA With Solitaire™ Revascularization Device IV t-PA
Hide Arm/Group Description:
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
IV infusion of tPA
Overall Number of Participants Analyzed 98 93
Measure Type: Count of Participants
Unit of Measure: Participants
59
  60.2%
33
  35.5%
4.Secondary Outcome
Title Change in NIH Stroke Scale Score at 27 ± 6 Hrs Post Randomization
Hide Description The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 – 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.
Time Frame Baseline to 27±6 hours post randomization
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Hide Analysis Population Description
Final assessment not available for all subjects.
Arm/Group Title IV t-PA With Solitaire™ Revascularization Device IV t-PA
Hide Arm/Group Description:
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
IV infusion of tPA
Overall Number of Participants Analyzed 97 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
-8.5  (7.1) -3.9  (6.2)
5.Secondary Outcome
Title Volume of Cerebral Infarction as Measured by a CT or MRI Scan at 27±6 Hours Post Randomization
Hide Description [Not Specified]
Time Frame 27±6 hours post randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Final assessment not available for all subjects.
Arm/Group Title IV t-PA With Solitaire™ Revascularization Device IV t-PA
Hide Arm/Group Description:
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
IV infusion of tPA
Overall Number of Participants Analyzed 97 94
Mean (Standard Deviation)
Unit of Measure: cc
60.2  (86) 65.9  (73.5)
6.Secondary Outcome
Title Reperfusion Measured by Reperfusion Ratio on CT or MRI Scan 27±6 Hours Post Randomization
Hide Description [Not Specified]
Time Frame 27±6 hours post randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Final assessment not available for all subjects.
Arm/Group Title IV t-PA With Solitaire™ Revascularization Device IV t-PA
Hide Arm/Group Description:
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
IV infusion of tPA
Overall Number of Participants Analyzed 64 52
Mean (Standard Deviation)
Unit of Measure: Reperfusion ratio
81  (67.3) 61.9  (53)
7.Secondary Outcome
Title Arterial Revascularization Measured by TICI 2b or 3 Following Device Use
Hide Description [Not Specified]
Time Frame Post procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Final assessment not available for all subjects.
Arm/Group Title IV t-PA With Solitaire™ Revascularization Device IV t-PA
Hide Arm/Group Description:
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
IV infusion of tPA
Overall Number of Participants Analyzed 83 0
Measure Type: Count of Participants
Unit of Measure: Participants
73
  88.0%
8.Secondary Outcome
Title Correlation of RAPID-assessed Core Infarct Volume With 27±6 Hours Post Randomization Stroke Infarction in Subjects Who Achieved TICI 2b-3 Reperfusion Without Intracranial Hemorrhage
Hide Description [Not Specified]
Time Frame 27±6 hours post randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Final assessment not available for all subjects.
Arm/Group Title IV t-PA With Solitaire™ Revascularization Device IV t-PA
Hide Arm/Group Description:
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
IV infusion of tPA
Overall Number of Participants Analyzed 58 0
Measure Type: Number
Unit of Measure: Correlation
0.46
9.Other Pre-specified Outcome
Title Incidence of All Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame Through 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the IV t-PA arm withdrew and requested all data be removed.
Arm/Group Title IV t-PA With Solitaire™ Revascularization Device IV t-PA
Hide Arm/Group Description:
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
IV infusion of tPA
Overall Number of Participants Analyzed 98 97
Measure Type: Count of Participants
Unit of Measure: Participants
35
  35.7%
30
  30.9%
10.Other Pre-specified Outcome
Title Incidence of sICH at 27±6 Hours Post Randomization
Hide Description [Not Specified]
Time Frame 27±6 hours post randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the IV t-PA arm withdrew and requested all data be removed.
Arm/Group Title IV t-PA With Solitaire™ Revascularization Device IV t-PA
Hide Arm/Group Description:
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
IV infusion of tPA
Overall Number of Participants Analyzed 98 97
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3
   3.1%
Time Frame 90 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV t-PA With Solitaire™ Revascularization Device IV t-PA
Hide Arm/Group Description Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR IV infusion of tPA
All-Cause Mortality
IV t-PA With Solitaire™ Revascularization Device IV t-PA
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IV t-PA With Solitaire™ Revascularization Device IV t-PA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/98 (35.71%)      30/97 (30.93%)    
Blood and lymphatic system disorders     
Anaemia   3/98 (3.06%)  3 0/97 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction   1/98 (1.02%)  1 0/97 (0.00%)  0
Atrial fibrillation   0/98 (0.00%)  0 1/97 (1.03%)  1
Bradycardia   1/98 (1.02%)  1 1/97 (1.03%)  1
Cardiac arrest   2/98 (2.04%)  2 0/97 (0.00%)  0
Cardiac failure congestive   1/98 (1.02%)  1 1/97 (1.03%)  1
Intracardiac thrombus   2/98 (2.04%)  2 0/97 (0.00%)  0
Ischaemic cardiomyopathy   1/98 (1.02%)  1 0/97 (0.00%)  0
Myocardial infarction   0/98 (0.00%)  0 1/97 (1.03%)  1
Sick sinus syndrome   1/98 (1.02%)  1 0/97 (0.00%)  0
Tachycardia   0/98 (0.00%)  0 2/97 (2.06%)  2
Gastrointestinal disorders     
Gastrointestinal haemorrhage   1/98 (1.02%)  1 0/97 (0.00%)  0
Ileus   2/98 (2.04%)  2 1/97 (1.03%)  1
Intestinal ischaemia   0/98 (0.00%)  0 1/97 (1.03%)  1
Lower gastrointestinal haemorrhage   1/98 (1.02%)  1 0/97 (0.00%)  0
Infections and infestations     
Clostridium colitis   0/98 (0.00%)  0 1/97 (1.03%)  1
Endocarditis   2/98 (2.04%)  2 0/97 (0.00%)  0
Escherichia sepsis   1/98 (1.02%)  1 0/97 (0.00%)  0
Parotitis   0/98 (0.00%)  0 1/97 (1.03%)  1
Pneumonia   0/98 (0.00%)  0 1/97 (1.03%)  1
Respiratory syncytial virus infection   0/98 (0.00%)  0 1/97 (1.03%)  1
Sepsis   2/98 (2.04%)  2 2/97 (2.06%)  2
Septic shock   0/98 (0.00%)  0 1/97 (1.03%)  1
Injury, poisoning and procedural complications     
Carotid artery restenosis   1/98 (1.02%)  1 0/97 (0.00%)  0
Fall   0/98 (0.00%)  0 1/97 (1.03%)  1
Joint dislocation   0/98 (0.00%)  0 1/97 (1.03%)  1
Procedural vomiting   1/98 (1.02%)  1 0/97 (0.00%)  0
Vascular pseudoaneurysm   1/98 (1.02%)  1 1/97 (1.03%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Appendix cancer   0/98 (0.00%)  0 1/97 (1.03%)  1
Pancreatic carcinoma metastatic   0/98 (0.00%)  0 1/97 (1.03%)  1
Nervous system disorders     
Brain oedema   3/98 (3.06%)  3 2/97 (2.06%)  2
Cerebral haemorrhage   1/98 (1.02%)  1 0/97 (0.00%)  0
Convulsion   1/98 (1.02%)  1 0/97 (0.00%)  0
Haemorrhagic transformation stroke   0/98 (0.00%)  0 4/97 (4.12%)  4
Hydrocephalus   0/98 (0.00%)  0 1/97 (1.03%)  1
Intracranial aneurysm   1/98 (1.02%)  1 0/97 (0.00%)  0
Intracranial pressure increased   1/98 (1.02%)  1 0/97 (0.00%)  0
Intraventricular haemorrhage   1/98 (1.02%)  1 0/97 (0.00%)  0
Ischaemic stroke   2/98 (2.04%)  3 6/97 (6.19%)  6
Status epilepticus   0/98 (0.00%)  0 1/97 (1.03%)  1
Stroke in evolution   7/98 (7.14%)  7 8/97 (8.25%)  8
Vasculitis cerebral   0/98 (0.00%)  0 1/97 (1.03%)  1
Psychiatric disorders     
Mental status changes   1/98 (1.02%)  1 1/97 (1.03%)  1
Renal and urinary disorders     
Haematuria   1/98 (1.02%)  1 0/97 (0.00%)  0
Renal failure   0/98 (0.00%)  0 1/97 (1.03%)  1
Renal failure acute   3/98 (3.06%)  3 2/97 (2.06%)  2
Renal infarct   0/98 (0.00%)  0 1/97 (1.03%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure   1/98 (1.02%)  1 0/97 (0.00%)  0
Chronic obstructive pulmonary disease   1/98 (1.02%)  1 0/97 (0.00%)  0
Haemoptysis   1/98 (1.02%)  1 0/97 (0.00%)  0
Hypoxia   1/98 (1.02%)  1 0/97 (0.00%)  0
Pneumonia aspiration   1/98 (1.02%)  1 2/97 (2.06%)  2
Pulmonary embolism   0/98 (0.00%)  0 1/97 (1.03%)  1
Respiratory arrest   0/98 (0.00%)  0 1/97 (1.03%)  1
Respiratory distress   0/98 (0.00%)  0 3/97 (3.09%)  3
Respiratory failure   2/98 (2.04%)  2 2/97 (2.06%)  2
Vascular disorders     
Arterial rupture   1/98 (1.02%)  1 0/97 (0.00%)  0
Deep vein thrombosis   1/98 (1.02%)  1 2/97 (2.06%)  2
Embolism arterial   1/98 (1.02%)  1 0/97 (0.00%)  0
Femoral artery embolism   0/98 (0.00%)  0 1/97 (1.03%)  1
Haematoma   0/98 (0.00%)  0 1/97 (1.03%)  1
Hypotension   0/98 (0.00%)  0 3/97 (3.09%)  3
Peripheral artery thrombosis   1/98 (1.02%)  1 0/97 (0.00%)  0
Vascular occlusion   1/98 (1.02%)  1 0/97 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV t-PA With Solitaire™ Revascularization Device IV t-PA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   91/98 (92.86%)      88/97 (90.72%)    
Blood and lymphatic system disorders     
Anaemia   8/98 (8.16%)  8 4/97 (4.12%)  4
Haemorrhagic anaemia   0/98 (0.00%)  0 1/97 (1.03%)  1
Heparin-induced thrombocytopenia   1/98 (1.02%)  1 0/97 (0.00%)  0
Leukocytosis   6/98 (6.12%)  6 1/97 (1.03%)  1
Thrombocytopenia   0/98 (0.00%)  0 1/97 (1.03%)  1
Cardiac disorders     
Acute myocardial infarction   1/98 (1.02%)  1 0/97 (0.00%)  0
Atrial fibrillation   5/98 (5.10%)  5 5/97 (5.15%)  5
Atrial flutter   0/98 (0.00%)  0 1/97 (1.03%)  1
Atrial thrombosis   1/98 (1.02%)  1 0/97 (0.00%)  0
Atrioventricular block first degree   0/98 (0.00%)  0 1/97 (1.03%)  1
Bradycardia   4/98 (4.08%)  4 7/97 (7.22%)  8
Cardiac arrest   2/98 (2.04%)  2 0/97 (0.00%)  0
Cardiac failure   1/98 (1.02%)  1 0/97 (0.00%)  0
Cardiac failure congestive   1/98 (1.02%)  1 1/97 (1.03%)  1
Cardiomyopathy   0/98 (0.00%)  0 1/97 (1.03%)  1
Intracardiac thrombus   2/98 (2.04%)  2 0/97 (0.00%)  0
Ischaemic cardiomyopathy   1/98 (1.02%)  1 0/97 (0.00%)  0
Myocardial infarction   0/98 (0.00%)  0 1/97 (1.03%)  1
Palpitations   2/98 (2.04%)  2 0/97 (0.00%)  0
Sick sinus syndrome   1/98 (1.02%)  1 0/97 (0.00%)  0
Sinus arrest   2/98 (2.04%)  2 0/97 (0.00%)  0
Supraventricular tachycardia   2/98 (2.04%)  2 0/97 (0.00%)  0
Tachycardia   8/98 (8.16%)  8 9/97 (9.28%)  9
Ventricular tachycardia   1/98 (1.02%)  1 2/97 (2.06%)  2
Ear and labyrinth disorders     
Vertigo   0/98 (0.00%)  0 1/97 (1.03%)  1
Endocrine disorders     
Hyperthyroidism   0/98 (0.00%)  0 1/97 (1.03%)  1
Hypothyroidism   1/98 (1.02%)  1 1/97 (1.03%)  1
Eye disorders     
Conjunctival haemorrhage   1/98 (1.02%)  1 0/97 (0.00%)  0
Dry eye   1/98 (1.02%)  1 1/97 (1.03%)  1
Eye haemorrhage   0/98 (0.00%)  0 1/97 (1.03%)  1
Optic neuropathy   1/98 (1.02%)  1 0/97 (0.00%)  0
Photopsia   1/98 (1.02%)  1 0/97 (0.00%)  0
Visual impairment   2/98 (2.04%)  2 1/97 (1.03%)  1
Gastrointestinal disorders     
Abdominal pain   1/98 (1.02%)  1 1/97 (1.03%)  1
Abdominal pain lower   0/98 (0.00%)  0 1/97 (1.03%)  1
Abdominal pain upper   1/98 (1.02%)  1 1/97 (1.03%)  1
Constipation   17/98 (17.35%)  18 15/97 (15.46%)  16
Dental caries   0/98 (0.00%)  0 1/97 (1.03%)  1
Diarrhoea   2/98 (2.04%)  2 4/97 (4.12%)  4
Dyspepsia   1/98 (1.02%)  1 0/97 (0.00%)  0
Dysphagia   8/98 (8.16%)  8 8/97 (8.25%)  8
Faecal incontinence   1/98 (1.02%)  1 0/97 (0.00%)  0
Gastritis   1/98 (1.02%)  1 0/97 (0.00%)  0
Gastrointestinal haemorrhage   1/98 (1.02%)  1 0/97 (0.00%)  0
Gastrooesophageal reflux disease   1/98 (1.02%)  1 1/97 (1.03%)  1
Haematemesis   1/98 (1.02%)  1 2/97 (2.06%)  2
Haemorrhoidal haemorrhage   1/98 (1.02%)  1 0/97 (0.00%)  0
Haemorrhoids   0/98 (0.00%)  0 1/97 (1.03%)  1
Ileus   2/98 (2.04%)  2 1/97 (1.03%)  1
Intestinal ischaemia   0/98 (0.00%)  0 1/97 (1.03%)  1
Lower gastrointestinal haemorrhage   1/98 (1.02%)  1 0/97 (0.00%)  0
Melaena   0/98 (0.00%)  0 1/97 (1.03%)  1
Mouth haemorrhage   1/98 (1.02%)  1 0/97 (0.00%)  0
Nausea   9/98 (9.18%)  9 6/97 (6.19%)  6
Oesophageal stenosis   0/98 (0.00%)  0 1/97 (1.03%)  1
Oral pain   1/98 (1.02%)  1 0/97 (0.00%)  0
Retroperitoneal haematoma   1/98 (1.02%)  1 0/97 (0.00%)  0
Salivary hypersecretion   0/98 (0.00%)  0 1/97 (1.03%)  1
Swollen tongue   1/98 (1.02%)  1 0/97 (0.00%)  0
Vomiting   7/98 (7.14%)  7 4/97 (4.12%)  4
General disorders     
Application site pruritus   1/98 (1.02%)  1 0/97 (0.00%)  0
Catheter site haematoma   1/98 (1.02%)  1 0/97 (0.00%)  0
Catheter site haemorrhage   1/98 (1.02%)  1 0/97 (0.00%)  0
Catheter site induration   1/98 (1.02%)  1 0/97 (0.00%)  0
Catheter site inflammation   1/98 (1.02%)  1 0/97 (0.00%)  0
Chest pain   0/98 (0.00%)  0 1/97 (1.03%)  1
Cyst   0/98 (0.00%)  0 1/97 (1.03%)  1
Discomfort   1/98 (1.02%)  1 0/97 (0.00%)  0
Extravasation   1/98 (1.02%)  1 0/97 (0.00%)  0
Fatigue   3/98 (3.06%)  4 0/97 (0.00%)  0
Impaired healing   1/98 (1.02%)  1 0/97 (0.00%)  0
Influenza like illness   0/98 (0.00%)  0 1/97 (1.03%)  1
Local swelling   2/98 (2.04%)  2 2/97 (2.06%)  2
Oedema peripheral   0/98 (0.00%)  0 4/97 (4.12%)  4
Pain   5/98 (5.10%)  5 3/97 (3.09%)  3
Polyp   1/98 (1.02%)  1 0/97 (0.00%)  0
Pyrexia   9/98 (9.18%)  9 7/97 (7.22%)  7
Systemic inflammatory response syndrome   1/98 (1.02%)  1 1/97 (1.03%)  1
Temperature intolerance   1/98 (1.02%)  1 0/97 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis acute   0/98 (0.00%)  0 1/97 (1.03%)  1
Cholelithiasis   1/98 (1.02%)  1 0/97 (0.00%)  0
Cholestasis   0/98 (0.00%)  0 1/97 (1.03%)  1
Hepatic cyst   1/98 (1.02%)  1 0/97 (0.00%)  0
Immune system disorders     
Drug hypersensitivity   2/98 (2.04%)  2 2/97 (2.06%)  2
Immune system disorder   0/98 (0.00%)  0 1/97 (1.03%)  1
Infections and infestations     
Acute sinusitis   1/98 (1.02%)  1 0/97 (0.00%)  0
Bacterial disease carrier   0/98 (0.00%)  0 1/97 (1.03%)  1
Bronchitis   0/98 (0.00%)  0 1/97 (1.03%)  1
Candida infection   1/98 (1.02%)  1 2/97 (2.06%)  2
Cellulitis   2/98 (2.04%)  2 1/97 (1.03%)  1
Clostridium colitis   0/98 (0.00%)  0 1/97 (1.03%)  1
Conjunctivitis   1/98 (1.02%)  1 0/97 (0.00%)  0
Cystitis   0/98 (0.00%)  0 1/97 (1.03%)  1
Endocarditis   2/98 (2.04%)  2 0/97 (0.00%)  0
Epididymitis   1/98 (1.02%)  1 0/97 (0.00%)  0
Escherichia sepsis   1/98 (1.02%)  1 0/97 (0.00%)  0
Fungal infection   0/98 (0.00%)  0 1/97 (1.03%)  1
Fungal skin infection   1/98 (1.02%)  1 0/97 (0.00%)  0
Gastroenteritis   1/98 (1.02%)  1 0/97 (0.00%)  0
Genital infection fungal   0/98 (0.00%)  0 1/97 (1.03%)  1
Hand-foot-and-mouth disease   0/98 (0.00%)  0 1/97 (1.03%)  1
Herpes zoster   0/98 (0.00%)  0 1/97 (1.03%)  1
Oral candidiasis   3/98 (3.06%)  3 4/97 (4.12%)  4
Parotitis   0/98 (0.00%)  0 1/97 (1.03%)  1
Pneumonia   13/98 (13.27%)  14 8/97 (8.25%)  8
Respiratory syncytial virus infection   0/98 (0.00%)  0 1/97 (1.03%)  1
Respiratory tract infection   2/98 (2.04%)  2 0/97 (0.00%)  0
Rhinitis   0/98 (0.00%)  0 1/97 (1.03%)  1
Sepsis   2/98 (2.04%)  2 3/97 (3.09%)  3
Septic shock   0/98 (0.00%)  0 1/97 (1.03%)  1
Sinusitis   1/98 (1.02%)  1 0/97 (0.00%)  0
Skin candida   1/98 (1.02%)  1 0/97 (0.00%)  0
Urinary tract infection   19/98 (19.39%)  21 29/97 (29.90%)  33
Wound infection   0/98 (0.00%)  0 1/97 (1.03%)  1
Injury, poisoning and procedural complications     
Ankle fracture   0/98 (0.00%)  0 1/97 (1.03%)  1
Carotid artery restenosis   1/98 (1.02%)  1 0/97 (0.00%)  0
Fall   3/98 (3.06%)  4 3/97 (3.09%)  3
Joint dislocation   0/98 (0.00%)  0 1/97 (1.03%)  1
Post procedural haematoma   1/98 (1.02%)  1 0/97 (0.00%)  0
Procedural pain   1/98 (1.02%)  1 0/97 (0.00%)  0
Procedural vomiting   1/98 (1.02%)  1 0/97 (0.00%)  0
Pseudomeningocele   0/98 (0.00%)  0 1/97 (1.03%)  1
Subdural haematoma   1/98 (1.02%)  1 1/97 (1.03%)  1
Tracheal injury   1/98 (1.02%)  1 0/97 (0.00%)  0
Vascular pseudoaneurysm   1/98 (1.02%)  1 1/97 (1.03%)  1
Investigations     
Biopsy salivary gland   1/98 (1.02%)  1 0/97 (0.00%)  0
Blood creatine phosphokinase increased   2/98 (2.04%)  2 0/97 (0.00%)  0
Blood creatinine increased   1/98 (1.02%)  1 0/97 (0.00%)  0
Blood glucose increased   1/98 (1.02%)  1 0/97 (0.00%)  0
Blood magnesium abnormal   1/98 (1.02%)  1 0/97 (0.00%)  0
Blood pressure increased   9/98 (9.18%)  10 8/97 (8.25%)  8
Blood urea increased   1/98 (1.02%)  1 1/97 (1.03%)  1
Cardiac enzymes increased   0/98 (0.00%)  0 1/97 (1.03%)  1
Electrocardiogram ST segment abnormal   0/98 (0.00%)  0 1/97 (1.03%)  1
Electrocardiogram ST segment depression   0/98 (0.00%)  0 1/97 (1.03%)  1
Glycosylated haemoglobin increased   0/98 (0.00%)  0 1/97 (1.03%)  1
Transaminases increased   2/98 (2.04%)  2 2/97 (2.06%)  2
Troponin increased   2/98 (2.04%)  2 1/97 (1.03%)  1
Urine output decreased   0/98 (0.00%)  0 1/97 (1.03%)  1
Weight decreased   1/98 (1.02%)  1 0/97 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite   1/98 (1.02%)  1 1/97 (1.03%)  1
Dehydration   1/98 (1.02%)  1 2/97 (2.06%)  2
Diabetes mellitus   0/98 (0.00%)  0 3/97 (3.09%)  3
Dyslipidaemia   2/98 (2.04%)  2 0/97 (0.00%)  0
Electrolyte imbalance   4/98 (4.08%)  4 7/97 (7.22%)  7
Fluid retention   0/98 (0.00%)  0 1/97 (1.03%)  1
Glucose tolerance impaired   1/98 (1.02%)  1 1/97 (1.03%)  1
Gout   1/98 (1.02%)  1 1/97 (1.03%)  1
Hypercholesterolaemia   1/98 (1.02%)  1 3/97 (3.09%)  3
Hyperglycaemia   7/98 (7.14%)  7 4/97 (4.12%)  4
Hyperlipidaemia   2/98 (2.04%)  2 0/97 (0.00%)  0
Hypernatraemia   2/98 (2.04%)  2 0/97 (0.00%)  0
Hypervolaemia   0/98 (0.00%)  0 2/97 (2.06%)  2
Hypocalcaemia   3/98 (3.06%)  3 2/97 (2.06%)  2
Hypokalaemia   18/98 (18.37%)  18 7/97 (7.22%)  7
Hypomagnesaemia   5/98 (5.10%)  5 4/97 (4.12%)  4
Hyponatraemia   3/98 (3.06%)  3 2/97 (2.06%)  2
Hypophosphataemia   1/98 (1.02%)  1 3/97 (3.09%)  3
Hypoproteinaemia   0/98 (0.00%)  0 1/97 (1.03%)  1
Malnutrition   0/98 (0.00%)  0 3/97 (3.09%)  3
Vitamin D deficiency   0/98 (0.00%)  0 1/97 (1.03%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia   3/98 (3.06%)  4 5/97 (5.15%)  6
Arthritis   1/98 (1.02%)  1 0/97 (0.00%)  0
Back pain   3/98 (3.06%)  3 3/97 (3.09%)  3
Groin pain   0/98 (0.00%)  0 2/97 (2.06%)  2
Joint swelling   1/98 (1.02%)  1 0/97 (0.00%)  0
Muscle spasms   1/98 (1.02%)  1 1/97 (1.03%)  1
Musculoskeletal chest pain   1/98 (1.02%)  1 0/97 (0.00%)  0
Musculoskeletal pain   1/98 (1.02%)  1 3/97 (3.09%)  3
Neck pain   0/98 (0.00%)  0 1/97 (1.03%)  1
Osteoarthritis   1/98 (1.02%)  1 1/97 (1.03%)  1
Pain in extremity   4/98 (4.08%)  4 4/97 (4.12%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Appendix cancer   0/98 (0.00%)  0 1/97 (1.03%)  1
Gastric cancer   1/98 (1.02%)  1 0/97 (0.00%)  0
Haemangioma of liver   0/98 (0.00%)  0 1/97 (1.03%)  1
Pancreatic carcinoma metastatic   0/98 (0.00%)  0 1/97 (1.03%)  1
Nervous system disorders     
Amnesia   1/98 (1.02%)  1 0/97 (0.00%)  0
Brain oedema   3/98 (3.06%)  3 2/97 (2.06%)  2
Carotid artery dissection   1/98 (1.02%)  1 0/97 (0.00%)  0
Carotid artery thrombosis   0/98 (0.00%)  0 1/97 (1.03%)  1
Cerebral artery embolism   1/98 (1.02%)  1 0/97 (0.00%)  0
Cerebral haemorrhage   1/98 (1.02%)  1 2/97 (2.06%)  2
Cerebral vasoconstriction   12/98 (12.24%)  12 0/97 (0.00%)  0
Complex regional pain syndrome   1/98 (1.02%)  1 2/97 (2.06%)  2
Convulsion   1/98 (1.02%)  1 6/97 (6.19%)  6
Dizziness   2/98 (2.04%)  2 1/97 (1.03%)  1
Encephalopathy   0/98 (0.00%)  0 1/97 (1.03%)  1
Haemorrhagic transformation stroke   32/98 (32.65%)  33 39/97 (40.21%)  40
Headache   16/98 (16.33%)  17 16/97 (16.49%)  16
Hemianopia   1/98 (1.02%)  1 1/97 (1.03%)  1
Horner's syndrome   1/98 (1.02%)  1 0/97 (0.00%)  0
Hydrocephalus   0/98 (0.00%)  0 1/97 (1.03%)  1
Hypertonia   0/98 (0.00%)  0 1/97 (1.03%)  1
Intracranial aneurysm   2/98 (2.04%)  2 0/97 (0.00%)  0
Intracranial pressure increased   2/98 (2.04%)  2 2/97 (2.06%)  2
Intraventricular haemorrhage   4/98 (4.08%)  4 3/97 (3.09%)  3
Ischaemic stroke   3/98 (3.06%)  4 9/97 (9.28%)  9
Lethargy   0/98 (0.00%)  0 1/97 (1.03%)  1
Migraine   0/98 (0.00%)  0 1/97 (1.03%)  1
Monoparesis   0/98 (0.00%)  0 1/97 (1.03%)  1
Muscle spasticity   2/98 (2.04%)  2 2/97 (2.06%)  2
Neuralgia   1/98 (1.02%)  1 0/97 (0.00%)  0
Paraesthesia   1/98 (1.02%)  1 0/97 (0.00%)  0
Partial seizures   0/98 (0.00%)  0 1/97 (1.03%)  1
Presyncope   1/98 (1.02%)  1 0/97 (0.00%)  0
Somnolence   1/98 (1.02%)  1 0/97 (0.00%)  0
Status epilepticus   0/98 (0.00%)  0 1/97 (1.03%)  1
Stroke in evolution   8/98 (8.16%)  8 8/97 (8.25%)  8
Subarachnoid haemorrhage   1/98 (1.02%)  1 1/97 (1.03%)  1
Syncope   0/98 (0.00%)  0 2/97 (2.06%)  2
Transient ischaemic attack   1/98 (1.02%)  1 0/97 (0.00%)  0
Tremor   0/98 (0.00%)  0 2/97 (2.06%)  2
Vasculitis cerebral   0/98 (0.00%)  0 1/97 (1.03%)  1
Psychiatric disorders     
Acute psychosis   1/98 (1.02%)  1 0/97 (0.00%)  0
Agitation   6/98 (6.12%)  6 8/97 (8.25%)  8
Alcohol withdrawal syndrome   1/98 (1.02%)  1 0/97 (0.00%)  0
Anxiety   2/98 (2.04%)  3 4/97 (4.12%)  4
Confusional state   0/98 (0.00%)  0 1/97 (1.03%)  1
Depressed mood   1/98 (1.02%)  1 0/97 (0.00%)  0
Depression   15/98 (15.31%)  15 15/97 (15.46%)  15
Depressive symptom   0/98 (0.00%)  0 1/97 (1.03%)  1
Insomnia   9/98 (9.18%)  9 5/97 (5.15%)  5
Mental status changes   1/98 (1.02%)  1 1/97 (1.03%)  1
Restlessness   1/98 (1.02%)  1 1/97 (1.03%)  1
Sleep disorder   0/98 (0.00%)  0 1/97 (1.03%)  1
Stress   1/98 (1.02%)  1 0/97 (0.00%)  0
Renal and urinary disorders     
Azotaemia   0/98 (0.00%)  0 1/97 (1.03%)  1
Dysuria   1/98 (1.02%)  1 1/97 (1.03%)  1
Haematuria   2/98 (2.04%)  2 3/97 (3.09%)  3
Hypertonic bladder   0/98 (0.00%)  0 1/97 (1.03%)  1
Oliguria   0/98 (0.00%)  0 1/97 (1.03%)  1
Polyuria   0/98 (0.00%)  0 1/97 (1.03%)  1
Renal failure   1/98 (1.02%)  1 1/97 (1.03%)  1
Renal failure acute   5/98 (5.10%)  5 4/97 (4.12%)  4
Renal infarct   0/98 (0.00%)  0 1/97 (1.03%)  1
Renal mass   1/98 (1.02%)  1 0/97 (0.00%)  0
Urethral pain   0/98 (0.00%)  0 1/97 (1.03%)  1
Urge incontinence   0/98 (0.00%)  0 1/97 (1.03%)  1
Urinary retention   9/98 (9.18%)  9 0/97 (0.00%)  0
Reproductive system and breast disorders     
Benign prostatic hyperplasia   2/98 (2.04%)  2 4/97 (4.12%)  4
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure   1/98 (1.02%)  1 0/97 (0.00%)  0
Aspiration   1/98 (1.02%)  1 0/97 (0.00%)  0
Atelectasis   3/98 (3.06%)  3 2/97 (2.06%)  2
Chronic obstructive pulmonary disease   2/98 (2.04%)  2 2/97 (2.06%)  2
Cough   1/98 (1.02%)  1 1/97 (1.03%)  1
Dyspnoea   2/98 (2.04%)  2 1/97 (1.03%)  1
Epistaxis   1/98 (1.02%)  1 0/97 (0.00%)  0
Haemoptysis   1/98 (1.02%)  1 0/97 (0.00%)  0
Hiccups   1/98 (1.02%)  1 2/97 (2.06%)  2
Hypoxia   2/98 (2.04%)  2 1/97 (1.03%)  1
Oropharyngeal pain   1/98 (1.02%)  1 1/97 (1.03%)  1
Pleural effusion   4/98 (4.08%)  4 2/97 (2.06%)  2
Pneumonia aspiration   7/98 (7.14%)  7 7/97 (7.22%)  7
Pulmonary congestion   1/98 (1.02%)  1 1/97 (1.03%)  1
Pulmonary embolism   0/98 (0.00%)  0 1/97 (1.03%)  1
Pulmonary oedema   4/98 (4.08%)  4 2/97 (2.06%)  2
Respiratory arrest   0/98 (0.00%)  0 1/97 (1.03%)  1
Respiratory distress   1/98 (1.02%)  1 4/97 (4.12%)  4
Respiratory failure   4/98 (4.08%)  4 2/97 (2.06%)  2
Sleep apnoea syndrome   1/98 (1.02%)  1 1/97 (1.03%)  1
Wheezing   1/98 (1.02%)  1 1/97 (1.03%)  1
Skin and subcutaneous tissue disorders     
Decubitus ulcer   6/98 (6.12%)  6 0/97 (0.00%)  0
Dermatitis   0/98 (0.00%)  0 1/97 (1.03%)  1
Dermatitis contact   0/98 (0.00%)  0 1/97 (1.03%)  1
Ecchymosis   1/98 (1.02%)  1 2/97 (2.06%)  2
Erythema   1/98 (1.02%)  1 3/97 (3.09%)  3
Intertrigo   1/98 (1.02%)  1 0/97 (0.00%)  0
Pruritus   1/98 (1.02%)  1 2/97 (2.06%)  2
Rash   2/98 (2.04%)  2 1/97 (1.03%)  1
Rash erythematous   0/98 (0.00%)  0 1/97 (1.03%)  1
Skin lesion   0/98 (0.00%)  0 1/97 (1.03%)  1
Surgical and medical procedures     
Gastrostomy tube removal   0/98 (0.00%)  0 1/97 (1.03%)  1
Vascular disorders     
Aortic aneurysm   0/98 (0.00%)  0 1/97 (1.03%)  1
Arterial rupture   1/98 (1.02%)  1 0/97 (0.00%)  0
Deep vein thrombosis   8/98 (8.16%)  8 7/97 (7.22%)  7
Embolism arterial   1/98 (1.02%)  1 0/97 (0.00%)  0
Femoral artery embolism   0/98 (0.00%)  0 1/97 (1.03%)  1
Haematoma   2/98 (2.04%)  2 1/97 (1.03%)  1
Hypertension   5/98 (5.10%)  5 4/97 (4.12%)  4
Hypotension   6/98 (6.12%)  6 6/97 (6.19%)  6
Lymphoedema   0/98 (0.00%)  0 1/97 (1.03%)  1
Peripheral artery thrombosis   1/98 (1.02%)  1 0/97 (0.00%)  0
Phlebitis   0/98 (0.00%)  0 1/97 (1.03%)  1
Phlebitis superficial   1/98 (1.02%)  1 0/97 (0.00%)  0
Thrombophlebitis   3/98 (3.06%)  3 1/97 (1.03%)  1
Thrombosis   1/98 (1.02%)  1 0/97 (0.00%)  0
Vascular occlusion   1/98 (1.02%)  1 0/97 (0.00%)  0
Vasospasm   3/98 (3.06%)  3 0/97 (0.00%)  0
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.
Physician shall not make any publication without providing Sponsor 30 days notice.If Sponsor determines that the proposed publication contains confidential information, Sponsor may require the delay of publication for a period of time not to exceed 90 days and may require that any confidential information be removed from the publication. Sponsor may also require Physician to delay publication until any factual errors or inaccuracies in the publication are corrected.
Results Point of Contact
Name/Title: Manish Gupta, Sr. Director of Medical Affairs
Organization: Medtronic
Phone: 949 297 5494
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT01657461     History of Changes
Other Study ID Numbers: NV-SFR004
First Submitted: August 2, 2012
First Posted: August 6, 2012
Results First Submitted: November 15, 2016
Results First Posted: May 18, 2017
Last Update Posted: May 18, 2017