Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study (SWIFT)

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: NCT01054560
Recruitment Status : Completed
First Posted : January 22, 2010
Results First Posted : October 26, 2016
Last Update Posted : October 26, 2016
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 Ischemic Stroke
Interventions Device: SOLITAIRE™ Device
Device: MERCI® Device
Enrollment 144
Recruitment Details Subject enrolled from Feb 2010 to Feb 2011. Subject randomized to Solitaire or Merci by baseline National Institutes of Health Stroke Scale Score.
Pre-assignment Details Study had Roll-in period. Participating centers in the United States were required to enroll two (2) roll-in subjects prior to the subject randomization. There were a total of 31 roll-in subjects. Only data from the randomized cohort was used for both primary efficacy analysis and the safety endpoint analysis.
Arm/Group Title SOLITAIRE™ Device MERCI® Device
Hide Arm/Group Description The SOLITAIRE™ Device (investigational device) is the experimental arm The MERCI® Device (control device) is commercially available.
Period Title: Overall Study
Started 58 55
Completed 45 27
Not Completed 13 28
Reason Not Completed
Death             10             21
Lost to Follow-up             2             5
Withdrawal by Subject             0             2
Physician Decision             1             0
Arm/Group Title SOLITAIRE™ Device MERCI® Device Total
Hide Arm/Group Description The SOLITAIRE™ Device (investigational device) is the experimental arm The MERCI® Device (control device) is commercially available. Total of all reporting groups
Overall Number of Baseline Participants 58 55 113
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 55 participants 113 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
  37.9%
22
  40.0%
44
  38.9%
>=65 years
36
  62.1%
33
  60.0%
69
  61.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 55 participants 113 participants
67.1  (12.0) 67.1  (11.1) 67.1  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 55 participants 113 participants
Female
30
  51.7%
27
  49.1%
57
  50.4%
Male
28
  48.3%
28
  50.9%
56
  49.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 55 participants 113 participants
United States 57 54 111
Europe 1 1 2
1.Primary Outcome
Title Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage
Hide Description

Successful arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes.

Thrombolysis in Myocardial Infarction (TIMI) score describes the distal flow perfusion and revascularization before and following therapy.

TIMI 0 - No perfusion (worst outcome) TIMI 1 - Perfusion past the initial occlusion, but no distal branch filling TIMI 2 - Perfusion with incomplete or slow distal branch filling TIMI 3 - Full perfusion with filling of all distal branches (best outcome)

Time Frame Immediately post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Data was unavailable for two subjects from the randomized Solitaire and one from the randomized Merci cohort. Thus, the Core Lab evaluated data from 56 in the Solitaire FR group and 54 in the Merci group.
Arm/Group Title SOLITAIRE™ Device MERCI® Device
Hide Arm/Group Description:
The SOLITAIRE™ Device (investigational device) is the experimental arm
The MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed 56 54
Measure Type: Number
Unit of Measure: Percent of Subjects
60.7 24.1
2.Primary Outcome
Title Study Device-related Serious Adverse Events (SAEs)
Hide Description Incidence of study device-related Serious Adverse Events (SAEs)
Time Frame 90 Day
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title SOLITAIRE™ Device MERCI® Device
Hide Arm/Group Description:
SOLITAIRE™ Device (investigational device) is the experimental arm
MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed 58 55
Measure Type: Number
Unit of Measure: percentage of subjects
9 16
3.Primary Outcome
Title Procedure-related Serious Adverse Events (SAEs)
Hide Description Incidence of study procedure-related Serious Adverse Events (SAEs)
Time Frame 90 Day
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title SOLITAIRE™ Device MERCI® Device
Hide Arm/Group Description:
SOLITAIRE™ Device (investigational device) is the experimental arm
MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed 58 55
Measure Type: Number
Unit of Measure: percentage of subjects
14 16
4.Secondary Outcome
Title Time to Initial Recanalization
Hide Description Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow
Time Frame post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size
Arm/Group Title SOLITAIRE™ Device MERCI® Device
Hide Arm/Group Description:
The SOLITAIRE™ Device (investigational device) is the experimental arm
The MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed 47 46
Mean (Standard Deviation)
Unit of Measure: minutes
47  (37.3) 58.7  (33.8)
5.Secondary Outcome
Title Good Neurological Outcome at 30 Days
Hide Description Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more
Time Frame 30 Days Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.
Arm/Group Title SOLITAIRE™ Device MERCI® Device
Hide Arm/Group Description:
The SOLITAIRE™ Device (investigational device) is the experimental arm
The MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed 55 51
Measure Type: Number
Unit of Measure: Percent of subjects
50.9 33.3
6.Secondary Outcome
Title Good Neurological Outcome 90 Days
Hide Description Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more
Time Frame 90 Days Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.
Arm/Group Title SOLITAIRE™ Device MERCI® Device
Hide Arm/Group Description:
The SOLITAIRE™ Device (investigational device) is the experimental arm
The MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed 55 48
Measure Type: Number
Unit of Measure: Percent of subjects
58.2 33.3
7.Secondary Outcome
Title Mortality
Hide Description Rate of Mortality
Time Frame 90 Days follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title SOLITAIRE™ Device MERCI® Device
Hide Arm/Group Description:
The SOLITAIRE™ Device (investigational device) is the experimental arm
The MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed 58 55
Measure Type: Number
Unit of Measure: Percentage of subjects
17.2 38.2
8.Secondary Outcome
Title Symptomatic Intracranial Hemorrhage
Hide Description Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title SOLITAIRE™ Device MERCI® Device
Hide Arm/Group Description:
The SOLITAIRE™ Device (investigational device) is the experimental arm
The MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed 58 55
Measure Type: Number
Unit of Measure: Percentage of subjects
1.7 10.9
9.Secondary Outcome
Title Non-fatal Stroke-related Morbidity
Hide Description Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events
Time Frame 90 Day
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title SOLITAIRE™ Device MERCI® Device
Hide Arm/Group Description:
SOLITAIRE™ Device (investigational device) is the experimental arm
MERCI® Device (control device) is commercially available.
Overall Number of Participants Analyzed 58 55
Measure Type: Number
Unit of Measure: percentage of subjects
43.1 32.7
Time Frame 90 Days
Adverse Event Reporting Description Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
 
Arm/Group Title The SOLITAIRE™ Device The MERCI® Device
Hide Arm/Group Description The SOLITAIRE™ Device (investigational device) is the experimental arm The MERCI® Device (control device) is commercially available.
All-Cause Mortality
The SOLITAIRE™ Device The MERCI® Device
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
The SOLITAIRE™ Device The MERCI® Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/58 (84.48%)      44/55 (80.00%)    
Blood and lymphatic system disorders     
Anaemia  1  9/58 (15.52%)  10 4/55 (7.27%)  4
Thrombocytopenia  1  1/58 (1.72%)  1 1/55 (1.82%)  1
Disseminated Intravascular Coagulation  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Cardiac disorders     
Atrial Fibrillation  1  11/58 (18.97%)  12 4/55 (7.27%)  4
Atrial Flutter  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Artrioventricular block  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Bradycardyia  1  1/58 (1.72%)  1 2/55 (3.64%)  2
Bundle branch block right  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Cardiac disorders  1  1/58 (1.72%)  1 1/55 (1.82%)  1
Cardiac failure congestive  1  2/58 (3.45%)  2 1/55 (1.82%)  1
Tachycardia  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Ventricular tachycardia  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Acute myocardial  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Arrhythmia  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Cardiac arrest  1  0/58 (0.00%)  0 3/55 (5.45%)  4
Mitral valve disease  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Sinus bradycardia  1  0/58 (0.00%)  0 2/55 (3.64%)  2
Supraventricular tachycardia  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Cardiomyopathy  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Eye disorders     
Retinal Artery Occlusion  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Vitreous detachment  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Gastrointestinal disorders     
Colitis  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Dysphagia  1  1/58 (1.72%)  1 4/55 (7.27%)  4
Gastrointestinal haemorrhage  1  1/58 (1.72%)  1 1/55 (1.82%)  2
Gastrointestinal ulcer  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Haematemesis  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Haematochezia  1  2/58 (3.45%)  2 0/55 (0.00%)  0
Intestinal ischaemia  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Nausea  1  0/58 (0.00%)  0 3/55 (5.45%)  3
Retroperitoneal haematoma  1  1/58 (1.72%)  1 1/55 (1.82%)  1
General disorders     
Catheter site haematoma  1  2/58 (3.45%)  2 0/55 (0.00%)  0
Device breakage  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Multi-organ failure  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Pyrexia  1  3/58 (5.17%)  3 3/55 (5.45%)  3
Catheter Site Haemorrhage  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis acute  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Cholecystitis  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Infections and infestations     
Wound infection  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Urinary tract infection  1  3/58 (5.17%)  3 6/55 (10.91%)  6
Tracheobronchitis  1  1/58 (1.72%)  1 1/55 (1.82%)  1
Sepsis  1  3/58 (5.17%)  3 2/55 (3.64%)  2
Pneumonia  1  2/58 (3.45%)  2 5/55 (9.09%)  5
Infusion site infection  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Febrile infection  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Clostridal infection  1  1/58 (1.72%)  1 1/55 (1.82%)  1
Bacterial disease carrier  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Bacteraemia  1  1/58 (1.72%)  1 2/55 (3.64%)  2
Injury, poisoning and procedural complications     
Vascular access complication  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Procedural hypertension  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Femoral nerve injury  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Toxicity to various agents  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Investigations     
Heart rate irregular  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Electrocardiogram abnormal  1  1/58 (1.72%)  1 1/55 (1.82%)  1
Echocardiogram abnormal  1  2/58 (3.45%)  2 0/55 (0.00%)  0
Lipids increased  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Breath sounds abnormal  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Blood creatinine  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Metabolism and nutrition disorders     
Hypoglycaemia  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Fluid overload  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Hypernatraemia  1  1/58 (1.72%)  1 1/55 (1.82%)  1
Malnutrition  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Pain in extremity  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer metastatic  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Nervous system disorders     
Brain oedema  1  2/58 (3.45%)  2 1/55 (1.82%)  1
Carotid artery dissection  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Carotid artery stenosis  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Cerebral artery occlusion  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Cerebral gas embolism  1  1/58 (1.72%)  1 3/55 (5.45%)  3
Cerebral haematoma  1  5/58 (8.62%)  5 8/55 (14.55%)  8
Cerebrovascular accident  1  7/58 (12.07%)  7 13/55 (23.64%)  13
Cerebrovascular spasm  1  3/58 (5.17%)  3 4/55 (7.27%)  4
Convulsion  1  0/58 (0.00%)  0 2/55 (3.64%)  2
Depressed level of consciousness  1  0/58 (0.00%)  0 2/55 (3.64%)  2
Encephalopathy  1  1/58 (1.72%)  1 1/55 (1.82%)  1
Haemorrhagic cerebral infarction  1  4/58 (6.90%)  4 3/55 (5.45%)  3
Intracranial pressure increased  1  2/58 (3.45%)  2 2/55 (3.64%)  2
Intraventricular haemorrhage  1  2/58 (3.45%)  2 2/55 (3.64%)  2
Ischaemic stroke  1  2/58 (3.45%)  2 7/55 (12.73%)  7
Lethargy  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Subarachnoid haemorrhage  1  3/58 (5.17%)  3 7/55 (12.73%)  7
Syncope  1  1/58 (1.72%)  1 1/55 (1.82%)  1
Tremor  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Psychiatric disorders     
Agitation  1  2/58 (3.45%)  2 0/55 (0.00%)  0
Confusional state  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Renal and urinary disorders     
Haematuria  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Hydronephrosis  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Renal failure  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Renal failure acute  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Urinary retention  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/58 (1.72%)  1 2/55 (3.64%)  2
Atelectasis  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Hypoxia  1  4/58 (6.90%)  4 1/55 (1.82%)  1
Increased bronchial secretion  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Lung infiltration  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Pleural effusion  1  0/58 (0.00%)  0 3/55 (5.45%)  3
Pneumonia aspiration  1  6/58 (10.34%)  6 3/55 (5.45%)  3
Productive cough  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Pulmonary embolism  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Pulmonary Oedema  1  2/58 (3.45%)  2 5/55 (9.09%)  5
Respiratory failure  1  5/58 (8.62%)  5 8/55 (14.55%)  8
Vascular disorders     
Air embolism  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Deep vein thrombosis  1  3/58 (5.17%)  3 2/55 (3.64%)  2
Femoral artery occlusion  1  0/58 (0.00%)  0 1/55 (1.82%)  1
Hypertension  1  4/58 (6.90%)  4 1/55 (1.82%)  1
Hypertensive crisis  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Hypotension  1  6/58 (10.34%)  7 5/55 (9.09%)  5
Intra-abdominal haemorrhage  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Peripheral ischaemia  1  1/58 (1.72%)  1 0/55 (0.00%)  0
Vasospasm  1  3/58 (5.17%)  3 3/55 (5.45%)  3
Vessel perforation  1  0/58 (0.00%)  0 2/55 (3.64%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
The SOLITAIRE™ Device The MERCI® Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/58 (63.79%)      30/55 (54.55%)    
Blood and lymphatic system disorders     
Anaemia  1  3/58 (5.17%)  3 3/55 (5.45%)  3
Thrombocytopenia  2  3/58 (5.17%)  3 0/55 (0.00%)  0
Cardiac disorders     
Bradycardia  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Arrhythmia  2  1/58 (1.72%)  1 1/55 (1.82%)  1
Tachycardia  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Cardiac failure congestive  2  1/58 (1.72%)  1 1/55 (1.82%)  1
Sinus Bradycardia  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Cardiomegaly  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Left ventricular dysfunction  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Atrial fibrillation  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Endocrine disorders     
Inappropriate antidiuretic hormone secretion  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Eye disorders     
Conjunctivitis  2  1/58 (1.72%)  1 1/55 (1.82%)  1
Diplopia  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Eye oedema  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Gastrointestinal disorders     
Nausea  2  1/58 (1.72%)  1 4/55 (7.27%)  5
Abdominal pain  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Dysphagia  2  2/58 (3.45%)  2 0/55 (0.00%)  0
Diarrhoea  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Constipation  2  1/58 (1.72%)  1 2/55 (3.64%)  2
Colitis ulcerative  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Dyspepsia  2  1/58 (1.72%)  1 0/55 (0.00%)  0
General disorders     
Adverse drug reaction  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Catheter site haematoma  2  1/58 (1.72%)  1 1/55 (1.82%)  1
Catheter site haemorrhage  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Oedema peripheral  2  1/58 (1.72%)  1 1/55 (1.82%)  1
Pyrexia  2  4/58 (6.90%)  4 3/55 (5.45%)  3
Unintentional medical device removal by patient  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Infections and infestations     
Candidiasis  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Cellulitis  2  2/58 (3.45%)  2 2/55 (3.64%)  2
Clostridial infection  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Oral candidiasis  2  2/58 (3.45%)  2 0/55 (0.00%)  0
Pneumonia  2  0/58 (0.00%)  0 2/55 (3.64%)  2
Urinary tract infection  2  12/58 (20.69%)  12 6/55 (10.91%)  7
Injury, poisoning and procedural complications     
Periorbital haematoma  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Vascular Pseudoaneurysm  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Laceration  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Urinary retention postoperative  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Fall  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Investigations     
Blood bilirubin increased  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Blood urea increased  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Differential white blood cell count abnormal  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Ejection fraction decreased  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Laboratory test abnormal  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Low density lipoprotein increased  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Protein total decreased  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Prothrombin time prolonged  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Troponin increased  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Metabolism and nutrition disorders     
Electrolyte imbalance  2  3/58 (5.17%)  3 2/55 (3.64%)  2
Fluid overload  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Gout  2  0/58 (0.00%)  0 2/55 (3.64%)  2
Hyperglycaemia  2  2/58 (3.45%)  2 4/55 (7.27%)  5
Hypernatraemia  2  1/58 (1.72%)  1 2/55 (3.64%)  2
Hypocalcaemia  2  2/58 (3.45%)  2 3/55 (5.45%)  3
Hypokalaemia  2  0/58 (0.00%)  0 4/55 (7.27%)  5
Hyponatraemia  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Hypomagnesaemia  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Metabolic acidosis  2  2/58 (3.45%)  2 1/55 (1.82%)  1
Type 2 diabetes mellitus  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Hypoglycaemia  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  2  2/58 (3.45%)  2 0/55 (0.00%)  0
Back pain  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Groin pain  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Pain in extremity  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Rheumatoid arthritis  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Upper extremity mass  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Musculoskeletal Pain  2  1/58 (1.72%)  1 2/55 (3.64%)  2
Nervous system disorders     
Brain oedema  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Carotid artery dissection  2  2/58 (3.45%)  2 0/55 (0.00%)  0
Cerebral haematoma  2  1/58 (1.72%)  1 2/55 (3.64%)  2
Cerebrovascular accident  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Haemorrhagic cerebral infarction  2  3/58 (5.17%)  3 2/55 (3.64%)  2
Headache  2  6/58 (10.34%)  6 2/55 (3.64%)  2
Intracranial pressure increased  2  2/58 (3.45%)  2 1/55 (1.82%)  1
Intraventricular haemorrhage  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Muscle spasticity  2  1/58 (1.72%)  1 1/55 (1.82%)  1
Subarachnoid haemorrhage  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Psychiatric disorders     
Anxiety  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Depression  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Mental status changes  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Renal and urinary disorders     
Oliguria  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Haematuria  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Reproductive system and breast disorders     
Genital rash  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Respiratory, thoracic and mediastinal disorders     
Atelectasis  2  4/58 (6.90%)  4 1/55 (1.82%)  1
Epistaxis  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Hyperventilation  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Hpoxia  2  2/58 (3.45%)  2 0/55 (0.00%)  0
Lung infiltration  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Pleural effusion  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Pulmonary oedema  2  1/58 (1.72%)  1 1/55 (1.82%)  1
Respiratory alkalosis  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Respiratory disorder  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Hypoventilation  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash maculo-papular  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Decubitus ulcer  2  0/58 (0.00%)  0 2/55 (3.64%)  2
Erythema  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Vascular disorders     
Deep vein thrombosis  2  0/58 (0.00%)  0 3/55 (5.45%)  3
Hypertension  2  2/58 (3.45%)  3 0/55 (0.00%)  0
Hypotension  2  0/58 (0.00%)  0 1/55 (1.82%)  1
Labile blood pressure  2  1/58 (1.72%)  1 0/55 (0.00%)  0
Thromophlebitis superficial  2  0/58 (0.00%)  0 2/55 (3.64%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
2
Term from vocabulary, MedDRA
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: Director of Clinical Affairs
Organization: Covidien
Phone: 9498373700
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT01054560     History of Changes
Other Study ID Numbers: SWIFT
First Submitted: December 10, 2009
First Posted: January 22, 2010
Results First Submitted: April 24, 2012
Results First Posted: October 26, 2016
Last Update Posted: October 26, 2016