Trial Outcomes & Findings for The WEB-IT Clinical Study (NCT NCT02191618)
NCT ID: NCT02191618
Last Updated: 2024-12-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
12 months
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
WEB Aneurysm Embolization Device
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.
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|---|---|
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Overall Study
STARTED
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150
|
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Overall Study
COMPLETED
|
143
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
WEB Aneurysm Embolization Device
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.
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|---|---|
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Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Missed Visit
|
4
|
Baseline Characteristics
Race and Ethnicity were not obtained for subjects from the European and Canadian sites.
Baseline characteristics by cohort
| Measure |
WEB Aneurysm Embolization Device
n=150 Participants
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.
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|---|---|
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Age, Continuous
|
58.98 years
STANDARD_DEVIATION 10.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Race and Ethnicity were not obtained for subjects from the European and Canadian sites.
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants • Race and Ethnicity were not obtained for subjects from the European and Canadian sites.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Race and Ethnicity were not obtained for subjects from the European and Canadian sites.
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants • Race and Ethnicity were not obtained for subjects from the European and Canadian sites.
|
|
Race (NIH/OMB)
White
|
98 Participants
n=5 Participants • Race and Ethnicity were not obtained for subjects from the European and Canadian sites.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Race and Ethnicity were not obtained for subjects from the European and Canadian sites.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
34 Participants
n=5 Participants • Race and Ethnicity were not obtained for subjects from the European and Canadian sites.
|
|
Region of Enrollment
United States
|
116 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
WEB Aneurysm Embolization Device
n=150 Participants
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.
|
|---|---|
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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.
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1 Participants
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PRIMARY outcome
Timeframe: 12 monthsPopulation: The overall number of participants analyzed is 143 due to 3 subjects withdrawing and 4 subjects that missed their 1 year follow up visit.
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.
Outcome measures
| Measure |
WEB Aneurysm Embolization Device
n=143 Participants
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.
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|---|---|
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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
|
77 Participants
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Adverse Events
CEC Adjudicated Adverse Events Through 1-Year
Serious events: 33 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CEC Adjudicated Adverse Events Through 1-Year
n=150 participants at risk
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.
|
|---|---|
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Cardiac disorders
Angina pectoris
|
0.67%
1/150 • Number of events 4 • 1 year
|
|
Cardiac disorders
Cardiac arrest
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0.67%
1/150 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
1.3%
2/150 • Number of events 2 • 1 year
|
|
Endocrine disorders
Cushing's syndrome
|
0.67%
1/150 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Crohn's disease
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Enteritis
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.3%
2/150 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
General disorders
Chest pain
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Infections and infestations
Cytomegalovirus infection
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Infections and infestations
Diverticulitis
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fracture
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Investigations
Blood pressure increased
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Nervous system disorders
Aphasia
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Nervous system disorders
Benign intracranial hypertension
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Nervous system disorders
Confusional state
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Nervous system disorders
Headache
|
1.3%
2/150 • Number of events 2 • 1 year
|
|
Nervous system disorders
Ischemic Stroke
|
4.0%
6/150 • Number of events 7 • 1 year
|
|
Nervous system disorders
Seizure
|
1.3%
2/150 • Number of events 2 • 1 year
|
|
Nervous system disorders
Subarachnoid hemorrhage
|
1.3%
2/150 • Number of events 2 • 1 year
|
|
Nervous system disorders
Syncope
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Nervous system disorders
TIA
|
2.0%
3/150 • Number of events 5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
2/150 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Vessel puncture site hematoma
|
2.7%
4/150 • Number of events 4 • 1 year
|
|
Vascular disorders
Arterial thrombosis
|
0.67%
1/150 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertension
|
1.3%
2/150 • Number of events 3 • 1 year
|
|
Vascular disorders
Vascular occlusion
|
0.67%
1/150 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
CEC Adjudicated Adverse Events Through 1-Year
n=150 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
6.7%
10/150 • Number of events 11 • 1 year
|
|
Vascular disorders
Vessel puncture site hematoma
|
5.3%
8/150 • Number of events 8 • 1 year
|
|
Nervous system disorders
Headache
|
24.0%
36/150 • Number of events 44 • 1 year
|
|
General disorders
Adverse drug reaction
|
9.3%
14/150 • Number of events 15 • 1 year
|
|
Eye disorders
Visual impairment
|
5.3%
8/150 • Number of events 8 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place