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Trial record 17 of 458 for:    ASPIRIN AND clopidogrel AND ischemic

VISSIT Intracranial Stent Study for Ischemic Therapy (VISSIT)

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: NCT00816166
Recruitment Status : Terminated
First Posted : December 31, 2008
Results First Posted : June 16, 2014
Last Update Posted : February 20, 2015
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ischemic Stroke
Transient Ischemic Attack
Interventions Device: Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel)
Drug: Aspirin and Clopidogrel (Medical therapy)
Enrollment 125
Recruitment Details Subjects were screened and enrolled at 27 sites worldwide (23 sites in the US and 4 sites outside of the US).
Pre-assignment Details 125 consented,of which 112 were randomized.Of 112,110 were treated (64 Stent Arm & 46 Med Therapy [MT] Arm).Of 112, 111 met criteria & in analysis pop (58 Stent Arm & 53 MT Arm).During course of the study,of 59 randomized to Stent Arm,4 treated w/MT Only & 1 failed to meet eligibility & excluded, & of 53 randomized to MT Arm, 9 treated w/Stent+MT.
Arm/Group Title Stent Group Medical Therapy Group
Hide Arm/Group Description

Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")

Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions.

Medical therapy alone (“Medical Therapy Group”)

Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)

Period Title: Overall Study
Started 59 [1] 53 [2]
ITT Population (Met Eligibility) 58 [3] 53
Completed 49 41
Not Completed 10 12
Reason Not Completed
Lost to Follow-up             6             10
Death             4             2
[1]
Of 59 randomized to Stent Arm, 4 were treated with Medical Therapy Only
[2]
Of 53 randomized to Medical Therapy Arm, 9 were treated with Stent+Medical Therapy
[3]
Of 59 randomized to Stent Arm, 1 subject failed to meet eligibility and was excluded from the ITT
Arm/Group Title Stent Group Medical Therapy Group Total
Hide Arm/Group Description

Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")

Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions.

Medical therapy alone (“Medical Therapy Group”)

Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)

Total of all reporting groups
Overall Number of Baseline Participants 58 53 111
Hide Baseline Analysis Population Description
Analyses were based on an Intent-to-Treat (ITT) population, defined ad enrolled subjects who met the inclusion/exclusion criteria and who were randomized post angiogram. Stent and medical Therapy Group subjects were analyzed to their ITT randomized group regardless of treatment received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 53 participants 111 participants
61.8  (12.3) 61.8  (12.8) 61.8  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 53 participants 111 participants
Female
17
  29.3%
21
  39.6%
38
  34.2%
Male
41
  70.7%
32
  60.4%
73
  65.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 53 participants 111 participants
Hispanic or Latino
5
   8.6%
2
   3.8%
7
   6.3%
Not Hispanic or Latino
53
  91.4%
51
  96.2%
104
  93.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 53 participants 111 participants
Asian 7 7 14
Native Hawaiian or Pacific Islander 0 0 0
Black or African American 4 5 9
White 42 38 80
Unknown or Not Reported 5 3 8
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 53 participants 111 participants
United States 47 42 89
China 7 7 14
Austria 4 4 8
1.Primary Outcome
Title Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months
Hide Description

The primary effectiveness endpoint was a composite of the two following outcomes:

  • Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization
  • Hard Transient Ischemic Attack (TIA) in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization

A subject was deemed to be a primary endpoint success if neither of these outcomes occurred.

The Kaplan-Meier success rate at 12-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of last follow-up, and the time variable for patients who were not successful (had a stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of the first event (stroke with 12 months or hard TIA between 2 days and 12 months).

Time Frame One Year
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were based on an intent-to-treat (ITT) population, defined as enrolled subjects who met the inclusion/exclusion criteria and who were randomized post angiogram. Stent and Medical Therapy Group subjects were analyzed according to their ITT randomized group regardless of treatment received.
Arm/Group Title Stent Group Medical Therapy Group
Hide Arm/Group Description:

Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")

Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions.

Medical therapy alone (“Medical Therapy Group”)

Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)

Overall Number of Participants Analyzed 58 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent probability
62.24
(48.15 to 73.15)
83.68
(69.94 to 91.50)
Time Frame Adverse events were collect from time of baseline angiogram/stent procedure through subject end of study (either early termination or 12 month post procedure follow up visit)
Adverse Event Reporting Description Adverse events collected and were summarized according to how they were reported by investigational sites
 
Arm/Group Title Stent Group Medical Therapy Group
Hide Arm/Group Description

Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")

Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions.

Medical therapy alone (“Medical Therapy Group”)

Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)

All-Cause Mortality
Stent Group Medical Therapy Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Stent Group Medical Therapy Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/58 (51.72%)      20/53 (37.74%)    
Blood and lymphatic system disorders     
Lymphadenopathy mediastinal * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Thrombocytopenia * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Cardiac disorders     
Angina pectoris * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Atrial fibrillation * 1  0/58 (0.00%)  0 2/53 (3.77%)  2
Bradycardia * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Chest pain * 1  0/58 (0.00%)  0 2/53 (3.77%)  2
Myocardial infarction * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Oedema peripheral * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Syncope * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Ventricular tachycardia * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Ear and labyrinth disorders     
Vertigo * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Endocrine disorders     
Hyperglycaemia * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Hypoglycaemia * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Gastrointestinal disorders     
Abdominal discomfort * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Abdominal pain * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Colitis ischaemic * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Gastrointestinal ulcer haemorrhage * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Haematochezia * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Nausea * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Pancreatitis acute * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Vomiting * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
General disorders     
Completed suicide * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Death * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Medical device pain * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Neurological symptom * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Stent malfunction * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Hepatobiliary disorders     
Hepatic cirrhosis * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Immune system disorders     
Drug hypersensitivity * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Infections and infestations     
Cellulitis * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Clostridium difficile colitis * 1  0/58 (0.00%)  0 2/53 (3.77%)  2
Infection * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Oral candidiasis * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Osteomyelitis * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Injury, poisoning and procedural complications     
Arterial restenosis * 1  2/58 (3.45%)  2 1/53 (1.89%)  1
Fall * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Overdose * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Vascular pseudoaneurysm * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Vascular rupture * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Hyperkalaemia * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Hypokalaemia * 1  1/58 (1.72%)  1 1/53 (1.89%)  1
Musculoskeletal and connective tissue disorders     
Rhabdomyolysis * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm malignant * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Prostate cancer * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Nervous system disorders     
Ataxia * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Cerebral infarction * 1  2/58 (3.45%)  2 0/53 (0.00%)  0
Cerebral ischaemia * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Cerebrovascular accident * 1  2/58 (3.45%)  2 1/53 (1.89%)  1
Convulsion * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Haemorrhage intracranial * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Haemorrhagic stroke * 1  2/58 (3.45%)  2 0/53 (0.00%)  0
Ischaemic stroke * 1  7/58 (12.07%)  7 4/53 (7.55%)  4
Muscular weakness * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Neurological symptom * 1  2/58 (3.45%)  2 0/53 (0.00%)  0
Post procedural stroke * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Transient ischaemic attack * 1  0/58 (0.00%)  0 2/53 (3.77%)  2
Vertebrobasilar insufficiency * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Vision blurred * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Visual field defect * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Psychiatric disorders     
Panic attack * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Suicide attempt * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Renal and urinary disorders     
Urinary retention * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Urinary tract infection * 1  3/58 (5.17%)  3 1/53 (1.89%)  1
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Pneumonia * 1  1/58 (1.72%)  1 1/53 (1.89%)  1
Pneumonia aspiration * 1  2/58 (3.45%)  2 1/53 (1.89%)  1
Surgical and medical procedures     
Amputation * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Carotid endarterectomy * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Hip arthroplasty * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Vascular disorders     
Aortic aneurysm * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Artery dissection * 1  2/58 (3.45%)  2 0/53 (0.00%)  0
Hypertension * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Hypotension * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Intermittent claudication * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Migraine * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Peripheral vascular disorder * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Transient ischaemic attack * 1  2/58 (3.45%)  2 4/53 (7.55%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stent Group Medical Therapy Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/58 (63.79%)      34/53 (64.15%)    
Blood and lymphatic system disorders     
Anaemia * 1  3/58 (5.17%)  3 2/53 (3.77%)  2
Coagulopathy * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Haemoglobin decreased * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Increased tendency to bruise * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Cardiac disorders     
Bradycardia * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Chest discomfort * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Chest pain * 1  0/58 (0.00%)  0 2/53 (3.77%)  2
Coronary Artery Disease * 1  1/58 (1.72%)  1 1/53 (1.89%)  1
Dizziness * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Dizziness postural * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Myocardial ischaemia * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Oedema peripheral * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Presyncope * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Syncope * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Ventricular tachycardia * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Ear and labyrinth disorders     
Vertigo * 1  2/58 (3.45%)  2 2/53 (3.77%)  2
Endocrine disorders     
Diabetic neuropathy * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Diabetic retinopathy * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Hyperglycaemia * 1  3/58 (5.17%)  3 0/53 (0.00%)  0
Hypoglycaemia * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Eye disorders     
Eye pain * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Retinal haemorrhage * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Visual field defect * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Dysphagia * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Gastrointestinal disorders     
Abdominal distension * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Barrett s oesophagus * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Constipation * 1  5/58 (8.62%)  5 1/53 (1.89%)  1
Dyspepsia * 1  2/58 (3.45%)  2 1/53 (1.89%)  1
Gastrointestinal disorder * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Haematochezia * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Hiatus hernia * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Inguinal hernia * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Mouth haemorrhage * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Nausea * 1  0/58 (0.00%)  0 2/53 (3.77%)  2
Oropharyngeal pain * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Post procedural diarrhoea * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
General disorders     
Fatigue * 1  2/58 (3.45%)  2 0/53 (0.00%)  0
Influenza like illness * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Lethargy * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Localised oedema * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Malaise * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Neurological complication associated with device * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Pain * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Pyrexia * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Infections and infestations     
Escherichia urinary tract infection * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Helicobacter infection * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Herpes zoster * 1  1/58 (1.72%)  1 1/53 (1.89%)  1
Infection * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Oral candidiasis * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Injury, poisoning and procedural complications     
Arterial restenosis * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Fall * 1  6/58 (10.34%)  6 4/53 (7.55%)  4
Phlebitis * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Post procedural haematuria * 1  1/58 (1.72%)  1 1/53 (1.89%)  1
Procedural hypotension * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Procedural nausea * 1  2/58 (3.45%)  2 1/53 (1.89%)  1
Procedural pain * 1  1/58 (1.72%)  1 1/53 (1.89%)  1
Procedural vomiting * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Investigations     
Blood creatine increased * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Blood glucose fluctuation * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Blood glucose increased * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Blood potassium abnormal * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Blood potassium decreased * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Blood testosterone decreased * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Hepatic enzyme increased * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Neurological examination abnormal * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Radial pulse decreased * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Red blood cell sedimentation rate increased * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Transaminases increased * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Dehydration * 1  1/58 (1.72%)  1 1/53 (1.89%)  1
Hyperlipidaemia * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Hypokalaemia * 1  3/58 (5.17%)  3 1/53 (1.89%)  1
Vitamin B12 deficiency * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Back Pain * 1  3/58 (5.17%)  3 0/53 (0.00%)  0
Intervertebral disc degeneration * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Joint dislocation * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Joint swelling * 1  2/58 (3.45%)  2 1/53 (1.89%)  1
Neck pain * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Pain in extremity * 1  1/58 (1.72%)  1 1/53 (1.89%)  1
Wrist fracture * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin cancer * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Nervous system disorders     
Aphasia * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Carpal tunnel syndrome * 1  1/58 (1.72%)  1 1/53 (1.89%)  1
Cerebral artery stenosis * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Cerebral haemorrhage * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Cerebral infarction * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Diabetic gastroparesis * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Diplopia * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Dysarthria * 1  1/58 (1.72%)  1 1/53 (1.89%)  1
Headache * 1  4/58 (6.90%)  5 3/53 (5.66%)  4
Hemiparesis * 1  2/58 (3.45%)  2 0/53 (0.00%)  0
Ischaemic stroke * 1  2/58 (3.45%)  2 0/53 (0.00%)  0
Neuralgia * 1  2/58 (3.45%)  3 0/53 (0.00%)  0
Neurological symptom * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Paraesthesia * 1  3/58 (5.17%)  4 2/53 (3.77%)  2
Post stroke depression * 1  2/58 (3.45%)  2 1/53 (1.89%)  1
Procedural headache * 1  1/58 (1.72%)  1 1/53 (1.89%)  1
Somnolence * 1  1/58 (1.72%)  1 1/53 (1.89%)  1
VIIth nerve paralysis * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Vision blurred * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Psychiatric disorders     
Anxiety * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Confusional state * 1  2/58 (3.45%)  2 0/53 (0.00%)  0
Depression * 1  2/58 (3.45%)  2 1/53 (1.89%)  1
Insomnia * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Memory impairment * 1  1/58 (1.72%)  1 1/53 (1.89%)  1
Withdrawal syndrome * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Renal and urinary disorders     
Dysuria * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Haematuria * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Micturition urgency * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Post procedural haematuria * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Renal cyst * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Renal failure * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Renal failure acute * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Urinary Retention * 1  2/58 (3.45%)  2 0/53 (0.00%)  0
Urinary tract infection * 1  5/58 (8.62%)  5 1/53 (1.89%)  2
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  2/58 (3.45%)  2 0/53 (0.00%)  0
Breast Mass * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Atelectasis * 1  1/58 (1.72%)  1 1/53 (1.89%)  1
Bronchitis * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Dyspnoea * 1  0/58 (0.00%)  0 1/53 (1.89%)  2
Pneumonia * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Pulmonary mass * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Radiation pneumonitis * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Sinus congestion * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Sinusitis * 1  2/58 (3.45%)  2 2/53 (3.77%)  2
Upper Respiratory Tract Infection * 1  2/58 (3.45%)  2 1/53 (1.89%)  1
Upper respiratory tract congestion * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dry gangrene * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Pruritus * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Rash * 1  3/58 (5.17%)  3 2/53 (3.77%)  2
Rash macular * 1  0/58 (0.00%)  0 1/53 (1.89%)  1
Surgical and medical procedures     
Cataract operation * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Tooth extraction * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Vascular disorders     
Artery dissection * 1  2/58 (3.45%)  2 0/53 (0.00%)  0
Contusion * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Epistaxis * 1  1/58 (1.72%)  1 1/53 (1.89%)  1
Haematoma * 1  0/58 (0.00%)  0 2/53 (3.77%)  2
Hypertension * 1  7/58 (12.07%)  9 7/53 (13.21%)  10
Hypotension * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Orthostatic hypotension * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Post procedural haematoma * 1  3/58 (5.17%)  4 0/53 (0.00%)  0
Post procedural haemorrhage * 1  1/58 (1.72%)  1 1/53 (1.89%)  1
Subclavian artery stenosis * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
Transient ischaemic attack * 1  2/58 (3.45%)  2 8/53 (15.09%)  12
Vasospasm * 1  4/58 (6.90%)  4 0/53 (0.00%)  0
Venous thrombosis * 1  1/58 (1.72%)  1 0/53 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Early termination of enrollment led to small numbers of subjects analyzed (less than 50% of the prospectively planned sample size). Various endpoints, subgroup and sensitivity analyses were not conducted because the study was not fully enrolled.
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
Name/Title: Jonathan Megerian, MD PhD
Organization: Codman Neuro
Phone: 508-880-8274
Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT00816166     History of Changes
Other Study ID Numbers: VISSIT CA-2007-01
G080051
First Submitted: December 29, 2008
First Posted: December 31, 2008
Results First Submitted: April 18, 2014
Results First Posted: June 16, 2014
Last Update Posted: February 20, 2015