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 : Unknown

Verified April 2020 by Microvention-Terumo, Inc..
Recruitment status was: Active, not recruiting

First Posted : July 16, 2014

Results First Posted : April 14, 2020

Last Update Posted : May 5, 2021

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Microvention-Terumo, 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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	WEB Aneurysm Embolization Device
Arm/Group Description	The WEB is an intra-aneurysmal devi...
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

Baseline Characteristics

Arm/Group Title		WEB Aneurysm Embolization Device
Arm/Group Description		The WEB is an intra-aneurysmal devi...
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
Baseline Analysis Population Description		[Not Specified]
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

Outcome Measures

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.
Description	The study's primary safety endpoint was the proportion of subjects wit...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	WEB Aneurysm Embolization Device
Arm/Group Description:	The WEB is an intra-aneurysmal devi...
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
Description	The primary effectiveness endpoint was defined as the percentage of su...
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

Outcome Measure Data

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
Arm/Group Description:	The WEB is an intra-aneurysmal devi...
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%

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	CEC Adjudicated Adverse Events Through 1-Year
Arm/Group Description	The WEB is an intra-aneurysmal devi...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Arthur AS, Molyneux A, Coon AL, Saatci I, Szikora I, Baltacioglu F, Sultan A, Hoit D, Delgado Almandoz JE, Elijovich L, Cekirge S, Byrne JV, Fiorella D; WEB-IT Study investigators. The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study. J Neurointerv Surg. 2019 Sep;11(9):924-930. doi: 10.1136/neurintsurg-2019-014815. Epub 2019 Apr 16.

Fiorella D, Molyneux A, Coon A, Szikora I, Saatci I, Baltacioglu F, Sultan A, Arthur A; WEB-IT Study Investigators. Demographic, procedural and 30-day safety results from the WEB Intra-saccular Therapy Study (WEB-IT). J Neurointerv Surg. 2017 Dec;9(12):1191-1196. doi: 10.1136/neurintsurg-2016-012841. Epub 2017 Jan 17.

Layout table for additonal information

Responsible Party:	Microvention-Terumo, 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

To Top