Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The WEB-IT Clinical Study (WEB-IT)

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: NCT02191618
Recruitment Status : Active, not recruiting
First Posted : July 16, 2014
Results First Posted : April 14, 2020
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Sequent Medical, Inc

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Wide Neck Bifurcation Intracranial Aneurysms
Intracranial Aneurysms
Intervention Device: WEB
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title WEB Aneurysm Embolization Device
Hide Arm/Group Description

The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.

The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.

Period Title: Overall Study
Started 150
Completed 143
Not Completed 7
Reason Not Completed
Withdrawal by Subject             3
Missed Visit             4
Arm/Group Title WEB Aneurysm Embolization Device
Hide Arm/Group Description

The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.

The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.

Overall Number of Baseline Participants 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants
58.98  (10.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
Female
110
  73.3%
Male
40
  26.7%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
14
   9.3%
White
98
  65.3%
More than one race
0
   0.0%
Unknown or Not Reported
34
  22.7%
[1]
Measure Analysis Population Description: Race and Ethnicity were not obtained for subjects from the European and Canadian sites.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 150 participants
United States 116
Turkey 20
Hungary 10
Canada 2
Denmark 1
Germany 1
1.Primary Outcome
Title The Primary Safety Endpoint Included Any Death or Major Stroke in the First 30 Days and Neurologic Death or Ipsilateral Major Stroke Between Day 31 and Day 365.
Hide Description The study's primary safety endpoint was the proportion of subjects with death of any nonaccidental cause or any major stroke (defined as an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale (NIHSS)) within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to 365 days after treatment.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title WEB Aneurysm Embolization Device
Hide Arm/Group Description:

The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.

The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.

Overall Number of Participants Analyzed 150
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.7%
2.Primary Outcome
Title Percentage of Subjects With Complete Aneurysm Occlusion Assessed Using the WEB Occlusion Scale (WOS) Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One Year After Treatment
Hide Description The primary effectiveness endpoint was defined as the percentage of subjects with complete aneurysm occlusion assessed using the WEB Occlusion Scale (WOS) without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (>50% stenosis) at one year after treatment in the mITT population.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed is 143 due to 3 subjects withdrawing and 4 subjects that missed their 1 year follow up visit.
Arm/Group Title WEB Aneurysm Embolization Device
Hide Arm/Group Description:

The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.

The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.

Overall Number of Participants Analyzed 143
Measure Type: Count of Participants
Unit of Measure: Participants
77
  53.8%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CEC Adjudicated Adverse Events Through 1-Year
Hide Arm/Group Description

The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.

The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.

All-Cause Mortality
CEC Adjudicated Adverse Events Through 1-Year
Affected / at Risk (%)
Total   0/150 (0.00%)    
Hide Serious Adverse Events
CEC Adjudicated Adverse Events Through 1-Year
Affected / at Risk (%) # Events
Total   33/150 (22.00%)    
Cardiac disorders   
Angina pectoris   1/150 (0.67%)  4
Cardiac arrest   1/150 (0.67%)  1
Coronary artery disease   2/150 (1.33%)  2
Endocrine disorders   
Cushing's syndrome   1/150 (0.67%)  2
Gastrointestinal disorders   
Crohn's disease   1/150 (0.67%)  1
Enteritis   1/150 (0.67%)  1
Gastrointestinal haemorrhage   2/150 (1.33%)  2
Impaired gastric emptying   1/150 (0.67%)  1
Vomiting   1/150 (0.67%)  1
General disorders   
Chest pain   1/150 (0.67%)  1
Hepatobiliary disorders   
Cholelithiasis   1/150 (0.67%)  1
Infections and infestations   
Cytomegalovirus infection   1/150 (0.67%)  1
Diverticulitis   1/150 (0.67%)  1
Pneumonia   1/150 (0.67%)  1
Injury, poisoning and procedural complications   
Fracture   1/150 (0.67%)  1
Investigations   
Blood pressure increased   1/150 (0.67%)  1
Musculoskeletal and connective tissue disorders   
Lumbar spinal stenosis   1/150 (0.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Meningioma   1/150 (0.67%)  1
Uterine leiomyoma   1/150 (0.67%)  1
Nervous system disorders   
Aphasia   1/150 (0.67%)  1
Benign intracranial hypertension   1/150 (0.67%)  1
Confusional state   1/150 (0.67%)  1
Haemorrhage intracranial   1/150 (0.67%)  1
Headache   2/150 (1.33%)  2
Ischemic Stroke   6/150 (4.00%)  7
Seizure   2/150 (1.33%)  2
Subarachnoid hemorrhage   2/150 (1.33%)  2
Syncope   1/150 (0.67%)  1
TIA   3/150 (2.00%)  5
Respiratory, thoracic and mediastinal disorders   
Hypoxia   1/150 (0.67%)  1
Pulmonary embolism   2/150 (1.33%)  2
Respiratory failure   1/150 (0.67%)  1
Tracheal stenosis   1/150 (0.67%)  1
Surgical and medical procedures   
Vessel puncture site hematoma   4/150 (2.67%)  4
Vascular disorders   
Arterial thrombosis   1/150 (0.67%)  1
Hypertension   2/150 (1.33%)  3
Vascular occlusion   1/150 (0.67%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CEC Adjudicated Adverse Events Through 1-Year
Affected / at Risk (%) # Events
Total   54/150 (36.00%)    
Eye disorders   
Visual impairment   8/150 (5.33%)  8
Gastrointestinal disorders   
Nausea   10/150 (6.67%)  11
General disorders   
Adverse drug reaction   14/150 (9.33%)  15
Nervous system disorders   
Headache   36/150 (24.00%)  44
Vascular disorders   
Vessel puncture site hematoma   8/150 (5.33%)  8
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: Director, Clinical Operations
Organization: Sequent Medical, Inc
Phone: 714-247-8000
EMail: anne.hurley@microvention.com
Layout table for additonal information
Responsible Party: Sequent Medical, Inc
ClinicalTrials.gov Identifier: NCT02191618    
Other Study ID Numbers: CP13-001
First Submitted: July 14, 2014
First Posted: July 16, 2014
Results First Submitted: February 18, 2020
Results First Posted: April 14, 2020
Last Update Posted: May 5, 2021