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Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device (PREMIER)

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: NCT02186561
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : May 21, 2019
Last Update Posted : December 27, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Intracranial Aneurysm
Intervention Device: Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device
Enrollment 197
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PREMIER
Hide Arm/Group Description The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
Period Title: Enrollment
Started [1] 197
Completed [2] 141
Not Completed 56
Reason Not Completed
Did Not Meet Inclusion Criteria             46
Enrollment Cap Reached             5
Insurance Denial             2
Withdrawal by Subject             2
Investigator Withdrew Consent             1
[1]
Participants Consented and Assessed for Eligibility
[2]
Enrolled Participants in Whom Deployment of the Investigational Device was Attempted- ITT Population
Period Title: Subjects Implanted With Device
Started [1] 141
Completed [2] 141
Not Completed 0
[1]
Participants with an Attempted Investigational Device Implant
[2]
Participants with a Successful Investigational Device Implant
Period Title: 30-Day Post Index Procedure Visit
Started [1] 141
Completed [2] 140
Not Completed 1
Reason Not Completed
Death             1
[1]
Participants implanted with the investigational device.
[2]
Participants Implanted with the Investigational Device that Completed the 30 Day Visit
Period Title: 180- Day Post Index Procedure Visit
Started [1] 141
Completed [2] 134
Not Completed 7
[1]
Participants implanted with the investigational device.
[2]
Participants Implanted with the Investigational Device that Completed the 30 Day Visit
Period Title: 1- Year Post Index Procedure Visit
Started [1] 141
Completed [2] 139
Not Completed 2
Reason Not Completed
Death             1
Missed             1
[1]
Participants implanted with the investigational device.
[2]
Participants Implanted with the Investigational Device that Completed the 1 Year Visit
Period Title: 2 - Year Post Index Procedure Visit
Started [1] 141
Completed [2] 134
Not Completed 7
[1]
Participants implanted with the investigational device.
[2]
Participants Implanted with the Investigational Device that Completed the 2 Year Visit
Period Title: 3 - Year Post Index Procedure Visit
Started [1] 141
Completed [2] 128
Not Completed 13
[1]
Participants implanted with the investigational device.
[2]
Participants Implanted with the Investigational Device that Completed the 3 Year Visit
Arm/Group Title PREMIER
Hide Arm/Group Description The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
Overall Number of Baseline Participants 141
Hide Baseline Analysis Population Description
Intent to Treat Population was defined as all enrolled participants in whom deployment of the Investigational device was attempted.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 141 participants
54.6  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants
Female
124
  87.9%
Male
17
  12.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants
Hispanic or Latino
12
   8.5%
Not Hispanic or Latino
115
  81.6%
Unknown or Not Reported
14
   9.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants
American Indian or Alaska Native
1
   0.7%
Asian
4
   2.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
16
  11.3%
White
114
  80.9%
More than one race
0
   0.0%
Unknown or Not Reported
6
   4.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 141 participants
Canada 6
United States 135
1.Primary Outcome
Title The Percentage of Participants With the Occurrence of Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 12-Months Post Procedure
Hide Description The primary safety endpoint was defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Missing data for subjects who failed to complete the 12- month post-procedure evaluation without any evidence of a major stroke in the territory supplied by the treated artery or neurological death were imputed in the analysis using multiple imputation. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.
Time Frame Up to 12 Months Post Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled and implanted with the Investigational Device (ITT)
Arm/Group Title PREMIER
Hide Arm/Group Description:
The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
Overall Number of Participants Analyzed 141
Measure Type: Number
Unit of Measure: percentage of participants
2.17
2.Primary Outcome
Title The Percentage of Participants With Complete Aneurysm Occlusion (Defined as Raymond Roy Grade 1) Without Significant Parent Artery Stenosis (≤ 50%) or Retreatment of the Target Aneurysm at 12-Months Post-Procedure
Hide Description

The definitions for the three components of the primary effectiveness endpoint were: 1) retreatment, defined as all retreatment procedures occurring between the index procedure and 1 Year post-procedure; 2) complete aneurysm occlusion based on Core Laboratory review of 1-year images and 3) significant parent artery stenosis, based on Core Laboratory review of 1-year images. The Raymond-Roy Grading scale is used for judging intracranial aneurysm (IA) endosaccular embolization success. Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac.

Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.

Time Frame Up to 12 Months Post Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Participants Treated with Investigational Device that Completed the 12 Month Visit Imaging
Arm/Group Title PREMIER
Hide Arm/Group Description:
The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
Overall Number of Participants Analyzed 141
Measure Type: Number
Unit of Measure: Percentage of Participants
76.71
3.Secondary Outcome
Title The Number of Participants With a Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 30-days Post Procedure Due to Procedural Complications
Hide Description Major Stroke is defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Neurological death is any subject death due to neurologic reasons.
Time Frame Up to 30 days, Post Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Participants Treated with the Investigational Device that Completed the 30 Day Visit
Arm/Group Title PREMIER
Hide Arm/Group Description:
The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
Overall Number of Participants Analyzed 141
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Secondary Outcome
Title The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-Procedure
Hide Description For the purpose of this protocol, delayed intracerebral hemorrhage was defined as hemorrhage within the fixed vault of the cranium (skull) occurring greater than 30 days post-procedure.
Time Frame > 30 days, Post Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
ParticipantsTreated with the Investigational Device that Completed the 30 Day Visit
Arm/Group Title PREMIER
Hide Arm/Group Description:
The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
Overall Number of Participants Analyzed 141
Measure Type: Number
Unit of Measure: Participants
1
5.Secondary Outcome
Title The Number of Participants With Successfully Deployed Investigational Device
Hide Description The secondary outcome measures provides the number of participants successfully implanted with the Investigational device during the study index procedure at the target site.
Time Frame Index Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Participants Enrolled who Underwent the Index Procedure
Arm/Group Title PREMIER
Hide Arm/Group Description:
The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
Overall Number of Participants Analyzed 141
Measure Type: Count of Participants
Unit of Measure: Participants
140
  99.3%
Time Frame Adverse Events were collected from the point of consent through year 3
Adverse Event Reporting Description

The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated.

Adjudicable events met the following criteria:

  • All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events)
  • All Device Related Adverse Events
  • All Procedure Related Adverse Events
  • All Serious Adverse Events (SAE’s)
 
Arm/Group Title CEC Adjudicated Adverse Events Through 1-Year CEC Adjudicated Adverse Events Through 2-Year CEC Adjudicated Adverse Events Through 3-Year
Hide Arm/Group Description Participants who received the Investigational Device followed through 1 Year Participants who received the Investigational Device followed through 2 Year Participants who received the Investigational Device followed through 3 Year
All-Cause Mortality
CEC Adjudicated Adverse Events Through 1-Year CEC Adjudicated Adverse Events Through 2-Year CEC Adjudicated Adverse Events Through 3-Year
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/141 (0.71%)      1/141 (0.71%)      2/141 (1.42%)    
Hide Serious Adverse Events
CEC Adjudicated Adverse Events Through 1-Year CEC Adjudicated Adverse Events Through 2-Year CEC Adjudicated Adverse Events Through 3-Year
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/141 (27.66%)      49/141 (34.75%)      60/141 (42.55%)    
Blood and lymphatic system disorders       
Anaemia  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  2
Lymphatic Disorder  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  2
Cardiac disorders       
Atrial flutter  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Cardiac failure congestive  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Coronary Artery Disease  1  0/141 (0.00%)  0 2/141 (1.42%)  2 3/141 (2.13%)  3
Ventricular tachycardia  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Cardiac Arrest  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Eye disorders       
Vision Blurred  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Gastrointestinal disorders       
Abdominal pain  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Gastrointestinal haemorrhage  1  3/141 (2.13%)  5 3/141 (2.13%)  5 3/141 (2.13%)  5
Nausea  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Pancreatitis  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Peritoneal haemorrhage  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Colitis  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Gastritis Erosive  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
General disorders       
Adverse drug reaction  1  2/141 (1.42%)  2 2/141 (1.42%)  2 2/141 (1.42%)  2
Chest pain  1  1/141 (0.71%)  1 2/141 (1.42%)  3 3/141 (2.13%)  4
Thrombosis in Device  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Hepatobiliary disorders       
Cholecystitis  1  0/141 (0.00%)  0 1/141 (0.71%)  1 2/141 (1.42%)  2
Portal vein thrombosis  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Immune system disorders       
Anaphylactic reaction  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Infections and infestations       
Colonic abscess  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Diverticulitis  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Gastroenteritis  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Influenza  1  1/141 (0.71%)  1 1/141 (0.71%)  1 2/141 (1.42%)  2
Pneumonia  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Upper Respiratory Tract Infection  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Wound Infection  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Bronchitis  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Bronchopulmonary Aspergillosis Allergic  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Injury, poisoning and procedural complications       
Patella Fracture  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Procedural hypertension  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Vascular Graft Occlusion  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Vascular pseudoaneurysm  1  1/141 (0.71%)  1 1/141 (0.71%)  1 2/141 (1.42%)  2
Overdose  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  2
Tibia Fracture  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Metabolism and nutrition disorders       
Dehydration  1  1/141 (0.71%)  2 1/141 (0.71%)  2 1/141 (0.71%)  2
Musculoskeletal and connective tissue disorders       
Back Pain  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Compartment syndrome  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma of colon  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Basal Cell Carcinoma  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Meningioma  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Nervous system disorders       
Carotid Artery Dissection  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Carotid artery stenosis  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Cerebral Haemorrhage  1  3/141 (2.13%)  3 4/141 (2.84%)  4 4/141 (2.84%)  4
Cerebral Infarction  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Convulsion  1  0/141 (0.00%)  0 3/141 (2.13%)  3 3/141 (2.13%)  3
Headache  1  4/141 (2.84%)  5 5/141 (3.55%)  6 6/141 (4.26%)  7
Ischaemic stroke  1  3/141 (2.13%)  4 3/141 (2.13%)  4 3/141 (2.13%)  4
Migraine  1  2/141 (1.42%)  2 3/141 (2.13%)  3 3/141 (2.13%)  3
Multiple sclerosis relapse  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  2
Myasthenia Gravis  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Presyncope  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Syncope  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Transient ischaemic attack  1  0/141 (0.00%)  0 2/141 (1.42%)  2 3/141 (2.13%)  3
Loss of Consciousness  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Paraesthesia  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Psychiatric disorders       
Delirium  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Depression  1  0/141 (0.00%)  0 1/141 (0.71%)  1 2/141 (1.42%)  2
Major depression  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  2
Suicide Attempt  1  1/141 (0.71%)  1 1/141 (0.71%)  1 2/141 (1.42%)  2
Suicidal Ideation  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Renal and urinary disorders       
Nephrolithiasis  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Renal failure chronic  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Ovarian cyst ruptured  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Menorrhagia  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Ovarian Cyst  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Respiratory, thoracic and mediastinal disorders       
Pulmonary Embolism  1  0/141 (0.00%)  0 2/141 (1.42%)  2 2/141 (1.42%)  2
Dyspnoea  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  2
Epistaxis  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  2
Skin and subcutaneous tissue disorders       
Stevens-Johnson Syndrome  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Surgical and medical procedures       
Aneurysm repair  1  5/141 (3.55%)  5 9/141 (6.38%)  9 9/141 (6.38%)  9
Coronary Arterial Stent Insertion  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Intervertebral Disc Operation  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Medical Device Removal  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Vascular disorders       
Haematoma  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Hypertensive Crisis  1  1/141 (0.71%)  1 3/141 (2.13%)  3 3/141 (2.13%)  5
Vascular Occlusion  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Malignant Hypertension  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Vascular Occlusion  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CEC Adjudicated Adverse Events Through 1-Year CEC Adjudicated Adverse Events Through 2-Year CEC Adjudicated Adverse Events Through 3-Year
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   107/141 (75.89%)      112/141 (79.43%)      112/141 (79.43%)    
Blood and lymphatic system disorders       
Haemorrhagic Diathesis  1  2/141 (1.42%)  2 2/141 (1.42%)  2 2/141 (1.42%)  2
Lymphoid tissue hyperplasia  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Ear and labyrinth disorders       
Vertigo  1  2/141 (1.42%)  2 2/141 (1.42%)  2 2/141 (1.42%)  2
Vertigo positional  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Eye disorders       
Amaurosis Fugax  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Blepharospasm  1  1/141 (0.71%)  1 2/141 (1.42%)  2 2/141 (1.42%)  2
Conjunctival Haemorrhage  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Diplopia  1  3/141 (2.13%)  3 3/141 (2.13%)  3 3/141 (2.13%)  3
Eye pain  1  2/141 (1.42%)  2 2/141 (1.42%)  2 2/141 (1.42%)  2
Photophobia  1  1/141 (0.71%)  2 2/141 (1.42%)  3 2/141 (1.42%)  3
Photopsia  1  2/141 (1.42%)  2 2/141 (1.42%)  2 2/141 (1.42%)  2
Vision blurred  1  7/141 (4.96%)  7 8/141 (5.67%)  8 8/141 (5.67%)  8
Visual impairment  1  15/141 (10.64%)  15 17/141 (12.06%)  17 17/141 (12.06%)  17
Vitreous detachment  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Vitreous floaters  1  5/141 (3.55%)  5 5/141 (3.55%)  5 5/141 (3.55%)  5
Gastrointestinal disorders       
Dysphagia  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Gastrointestinal inflammation  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Hiatus hernia  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Nausea  1  3/141 (2.13%)  3 3/141 (2.13%)  3 3/141 (2.13%)  3
General disorders       
Adverse drug reaction  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Catheter site haematoma  1  13/141 (9.22%)  13 13/141 (9.22%)  13 13/141 (9.22%)  13
Catheter site haemorrhage  1  9/141 (6.38%)  9 9/141 (6.38%)  9 9/141 (6.38%)  9
Catheter site pain  1  6/141 (4.26%)  6 6/141 (4.26%)  6 6/141 (4.26%)  6
Fatigue  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Local swelling  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Catheter Site Injury  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Infections and infestations       
Catheter site infection  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Injury, poisoning and procedural complications       
Concussion  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Fall  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Head injury  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Periorbital Haemorrhage  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Vascular pseudoaneurysm  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Investigations       
Modified Rankin Score Decreased  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Metabolism and nutrition disorders       
Hypervolaemia  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Hypovolaemia  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Hypokalaemia  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Musculoskeletal and connective tissue disorders       
Muscular weakness  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Musculoskeletal pain  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Neck pain  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Pain in extremity  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Spinal Osteoarthritis  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Back Pain  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasm  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Nervous system disorders       
Aphasia  1  3/141 (2.13%)  3 4/141 (2.84%)  4 4/141 (2.84%)  4
Ataxia  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Balance disorder  1  3/141 (2.13%)  3 3/141 (2.13%)  3 3/141 (2.13%)  3
Carpal Tunnel Syndrome  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Cerebral infarction  1  2/141 (1.42%)  2 2/141 (1.42%)  2 2/141 (1.42%)  2
Cerebral vasoconstriction  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Convulsion  1  0/141 (0.00%)  0 1/141 (0.71%)  1 2/141 (1.42%)  2
Disturbance in attention  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Dizziness  1  5/141 (3.55%)  6 9/141 (6.38%)  11 9/141 (6.38%)  12
Dysarthria  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Haemorrhage intracranial  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Headache  1  33/141 (23.40%)  35 34/141 (24.11%)  38 38/141 (26.95%)  44
Hemiparesis  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Hypoaesthesia  1  2/141 (1.42%)  2 2/141 (1.42%)  2 2/141 (1.42%)  2
Intracranial Artery Dissection  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Ischaemic Stroke  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Migraine  1  2/141 (1.42%)  2 2/141 (1.42%)  2 2/141 (1.42%)  2
Muscle spasticity  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Neuropathy peripheral  1  2/141 (1.42%)  2 2/141 (1.42%)  2 2/141 (1.42%)  2
Paraesthesia  1  5/141 (3.55%)  5 6/141 (4.26%)  6 7/141 (4.96%)  7
Presyncope  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Radiculitis Lumbosacral  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Radiculopathy  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Sensory Disturbance  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Subarachnoid Heamorrhage  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Syncope  1  3/141 (2.13%)  3 4/141 (2.84%)  4 4/141 (2.84%)  4
Transient Ischaemic Attack  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Tremor  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Visual field defect  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Cognitive Disorder  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Monoplegia  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
Psychiatric disorders       
Anxiety  1  0/141 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1
Confusional state  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Dysphemia  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Mental status changes  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Reproductive system and breast disorders       
Menorrhagia  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Respiratory, thoracic and mediastinal disorders       
Epistaxis  1  4/141 (2.84%)  4 4/141 (2.84%)  4 4/141 (2.84%)  4
Skin and subcutaneous tissue disorders       
Alopecia  1  2/141 (1.42%)  2 2/141 (1.42%)  2 2/141 (1.42%)  2
Ecchymosis  1  28/141 (19.86%)  28 29/141 (20.57%)  29 29/141 (20.57%)  29
Petechiae  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Swelling Face  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Vascular disorders       
Arterial stenosis  1  4/141 (2.84%)  4 4/141 (2.84%)  4 6/141 (4.26%)  6
Deep vein thrombosis  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Flushing  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Haematoma  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Haemorrhage  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Hypotension  1  1/141 (0.71%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1
Vasospasm  1  28/141 (19.86%)  29 28/141 (19.86%)  29 29/141 (20.57%)  31
Deep Vein Thrombosis  1  0/141 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Senior Project Manager, Clinical Project Management
Organization: Medtronic Neurovascular, Clinical Affairs
Phone: 949-680-1274
EMail: darren.j.lacour@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT02186561    
Obsolete Identifiers: NCT02178007
Other Study ID Numbers: NV-PED-07
First Submitted: July 8, 2014
First Posted: July 10, 2014
Results First Submitted: April 4, 2019
Results First Posted: May 21, 2019
Last Update Posted: December 27, 2019