The WEB-IT Clinical Study

• Sponsor: Sequent Medical, Inc (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02191618
• Collaborator: (none)
• Enrollment: 150
• Locations: 32
• Arm: 1
• Anticipated Duration (Months): 82
• Patients Per Site: 4.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The study is a prospective, multicenter single-arm cohort. Patients with wide neck bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular treatment. In this study, all patients with qualifying WNBAs will be treated with the WEB. The primary effectiveness outcome of the study is the likelihood of complete intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

Condition or Disease	Intervention/Treatment	Phase
Wide Neck Bifurcation Intracranial Aneurysms; Intracranial Aneurysms	Device: WEB	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The WEB® Intrasaccular Therapy Study (WEB-IT)
• Actual Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Sep 1, 2017
• Anticipated Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Device: WEB; The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.; Other Names: WEB Aneurysm Embolization Device

Outcome Measures

Primary Outcome Measures

1. 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. [12 months]

   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.

2. 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 [12 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient whose age ≥18 and ≤75 years.

• Patient must have a single ruptured or unruptured IA (intracranial aneurysm) requiring treatment.

• Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.

Exclusion Criteria:

• Patient has an IA with characteristics unsuitable for endovascular treatment

• Patient has stroke-in-evolution within the prior 60 days

• Patient has had an SAH (subarachnoid hemorrhage) from a nonindex IA or any other intracranial hemorrhage within 90 days

• Patient's index IA was previously treated

• Patient is pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barrow Neurological Institute	Phoenix	Arizona	United States	85013
2	Sequent Medical	Aliso Viejo	California	United States	92565
3	Radiology Imaging Associates P.C.	Englewood	Colorado	United States	80112
4	Lyerly Baptist, Inc	Jacksonville	Florida	United States	32207
5	Rush University Medical Center	Chicago	Illinois	United States	60612
6	University of Louisville	Louisville	Kentucky	United States	40202
7	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
8	Brigham and Women's Hospital	Boston	Massachusetts	United States	021115
9	Tufts Medical Center	Boston	Massachusetts	United States	02111
10	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
11	Mayo Clinic	Rochester	Minnesota	United States	55905
12	Albany Medical Center	Albany	New York	United States	12208
13	Buffalo General Medical Center	Buffalo	New York	United States	14203
14	The Mount Sinai Medical Center	New York	New York	United States	10029
15	Stony Brook University	Stony Brook	New York	United States	11794
16	Carolina NeuroSurgery & Spine Associates, P.A.	Charlotte	North Carolina	United States	28204
17	Riverside Methodist Hospital/ Ohio Health Research Institute	Columbus	Ohio	United States	43214
18	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
19	Medical University of South Carolina (MUSC)	Charleston	South Carolina	United States	29425
20	Ft. Sanders Regional Medical Center	Knoxville	Tennessee	United States	37916
21	Methodist University Hospital	Memphis	Tennessee	United States	38104
22	Baptist Memorial Hospital	Memphis	Tennessee	United States	38120
23	Baylor College of Medicine	Houston	Texas	United States	77030
24	University of Texas Health Science Center at Houston	Houston	Texas	United States	77030
25	University of Utah Medical Center	Salt Lake City	Utah	United States	84132
26	West Virginia University	Morgantown	West Virginia	United States	26505
27	Royal University Hospital	Saskatoon	Saskatchewan	Canada	S7N 0W8
28	Rigshospitalet	Copenhagen		Denmark	2100
29	Helios Hospital	Erfurt		Germany	99028
30	National Institute of Neurosciences	Budapest		Hungary	1145
31	Koru Hospital	Ankara		Turkey
32	Marmara University Faculty of Medicine Pendik Training and Research Hospital	Istanbul		Turkey

Sponsors and Collaborators

• Sequent Medical, Inc

Investigators

• Principal Investigator: Adam Arthur, MD, Methodist University Hospital, Memphis, TN
• Principal Investigator: David Fiorella, MD, Stony Brook University, Stony Brook, NY

Study Documents (Full-Text)

• Study Protocol - Aug 12, 2015
• Statistical Analysis Plan - Aug 12, 2015

More Information

Publications

None provided.

• Responsible Party: Sequent Medical, Inc
• ClinicalTrials.gov Identifier: NCT02191618
• Other Study ID Numbers: CP13-001
• First Posted: Jul 16, 2014
• Last Update Posted: May 5, 2021
• Last Verified: Apr 1, 2020

• Keywords provided by Sequent Medical, Inc: Aneurysm; Intracranial Aneurysm; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases
• Additional relevant MeSH terms: Intracranial Aneurysm; Aneurysm

Study Results

Participant Flow

Arm/Group Title	WEB Aneurysm Embolization Device
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

Baseline Characteristics

Arm/Group Title	WEB Aneurysm Embolization Device
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 Participants	150
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.98 (10.16)
Sex: Female, Male (Count of Participants)
Female	110 73.3%
Male	40 26.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	4 2.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	14 9.3%
White	98 65.3%
More than one race	0 0%
Unknown or Not Reported	34 22.7%
Region of Enrollment (participants) [Number]
United States	116 77.3%
Turkey	20 13.3%
Hungary	10 6.7%
Canada	2 1.3%
Denmark	1 0.7%
Germany	1 0.7%

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 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 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.
Measure Participants	150
Count of Participants [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 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 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.
Measure Participants	143
Count of Participants [Participants]	77 51.3%

Adverse Events

Time Frame	1 year
Arm/Group Title	CEC Adjudicated Adverse Events Through 1-Year
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 (%)	# Events
Total	0/150 (0%)
Serious Adverse Events
	CEC Adjudicated Adverse Events Through 1-Year
	Affected / at Risk (%)	# Events
Total	33/150 (22%)
Cardiac disorders
Angina pectoris	1/150 (0.7%)	4
Cardiac arrest	1/150 (0.7%)	1
Coronary artery disease	2/150 (1.3%)	2
Endocrine disorders
Cushing's syndrome	1/150 (0.7%)	2
Gastrointestinal disorders
Crohn's disease	1/150 (0.7%)	1
Enteritis	1/150 (0.7%)	1
Gastrointestinal haemorrhage	2/150 (1.3%)	2
Impaired gastric emptying	1/150 (0.7%)	1
Vomiting	1/150 (0.7%)	1
General disorders
Chest pain	1/150 (0.7%)	1
Hepatobiliary disorders
Cholelithiasis	1/150 (0.7%)	1
Infections and infestations
Cytomegalovirus infection	1/150 (0.7%)	1
Diverticulitis	1/150 (0.7%)	1
Pneumonia	1/150 (0.7%)	1
Injury, poisoning and procedural complications
Fracture	1/150 (0.7%)	1
Investigations
Blood pressure increased	1/150 (0.7%)	1
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis	1/150 (0.7%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma	1/150 (0.7%)	1
Uterine leiomyoma	1/150 (0.7%)	1
Nervous system disorders
Aphasia	1/150 (0.7%)	1
Benign intracranial hypertension	1/150 (0.7%)	1
Confusional state	1/150 (0.7%)	1
Haemorrhage intracranial	1/150 (0.7%)	1
Headache	2/150 (1.3%)	2
Ischemic Stroke	6/150 (4%)	7
Seizure	2/150 (1.3%)	2
Subarachnoid hemorrhage	2/150 (1.3%)	2
Syncope	1/150 (0.7%)	1
TIA	3/150 (2%)	5
Respiratory, thoracic and mediastinal disorders
Hypoxia	1/150 (0.7%)	1
Pulmonary embolism	2/150 (1.3%)	2
Respiratory failure	1/150 (0.7%)	1
Tracheal stenosis	1/150 (0.7%)	1
Surgical and medical procedures
Vessel puncture site hematoma	4/150 (2.7%)	4
Vascular disorders
Arterial thrombosis	1/150 (0.7%)	1
Hypertension	2/150 (1.3%)	3
Vascular occlusion	1/150 (0.7%)	1
Other (Not Including Serious) Adverse Events
	CEC Adjudicated Adverse Events Through 1-Year
	Affected / at Risk (%)	# Events
Total	54/150 (36%)
Eye disorders
Visual impairment	8/150 (5.3%)	8
Gastrointestinal disorders
Nausea	10/150 (6.7%)	11
General disorders
Adverse drug reaction	14/150 (9.3%)	15
Nervous system disorders
Headache	36/150 (24%)	44
Vascular disorders
Vessel puncture site hematoma	8/150 (5.3%)	8

Limitations/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.