The WEB-IT Clinical Study

Intracranial Aneurysms Clinical Trial

— WEB-IT  

Official title:

The WEB® Intrasaccular Therapy Study (WEB-IT)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02191618
• Other study ID #: CP13-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: June 2021

Study information

• Verified date: April 2020
• Source: Sequent Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 2021
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms
• Wide Neck Bifurcation Intracranial Aneurysms

Intervention

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

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Denmark	Rigshospitalet	Copenhagen
Germany	Helios Hospital	Erfurt
Hungary	National Institute of Neurosciences	Budapest
Turkey	Koru Hospital	Ankara
Turkey	Marmara University Faculty of Medicine Pendik Training and Research Hospital	Istanbul
United States	Albany Medical Center	Albany	New York
United States	Sequent Medical	Aliso Viejo	California
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Buffalo General Medical Center	Buffalo	New York
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Carolina NeuroSurgery & Spine Associates, P.A.	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Riverside Methodist Hospital/ Ohio Health Research Institute	Columbus	Ohio
United States	Radiology Imaging Associates P.C.	Englewood	Colorado
United States	Baylor College of Medicine	Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Lyerly Baptist, Inc	Jacksonville	Florida
United States	Ft. Sanders Regional Medical Center	Knoxville	Tennessee
United States	University of Louisville	Louisville	Kentucky
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Methodist University Hospital	Memphis	Tennessee
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	West Virginia University	Morgantown	West Virginia
United States	The Mount Sinai Medical Center	New York	New York
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Utah Medical Center	Salt Lake City	Utah
United States	Stony Brook University	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sequent Medical, Inc

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Germany,  Hungary,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	12 months
Primary	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	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.	12 months