The WEB-IT Clinical Study (WEB-IT)

• ClinicalTrials.gov Identifier: NCT02191618
• Recruitment Status: Unknown
• First Posted: July 16, 2014
• Results First Posted: April 14, 2020
• Last Update Posted: May 5, 2021
• Sponsor: Microvention-Terumo, Inc.
• Information provided by (Responsible Party): Microvention-Terumo, Inc.

Tracking Information

• First Submitted Date: July 14, 2014
• First Posted Date: July 16, 2014
• Results First Submitted Date: February 18, 2020
• Results First Posted Date: April 14, 2020
• Last Update Posted Date: May 5, 2021
• Actual Study Start Date: August 2014
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 13, 2020)

• 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. [ Time Frame: 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.
• 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 [ Time Frame: 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.

Original Primary Outcome Measures (submitted: July 15, 2014)

Primary Safety Outcome [ Time Frame: 12 months ]

The proportion of subjects with death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The WEB-IT Clinical Study
• Official Title: The WEB® Intrasaccular Therapy Study (WEB-IT)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Wide Neck Bifurcation Intracranial Aneurysms
• Intracranial Aneurysms

Intervention

Device: WEB

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

Other Name: WEB Aneurysm Embolization Device

Study Arms

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.

Intervention: Device: WEB

Publications *

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: July 7, 2015): 150
• Original Estimated Enrollment (submitted: July 15, 2014): 139
• Estimated Study Completion Date: June 2021
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Denmark, Germany, Hungary, Turkey, United States

Administrative Information

• NCT Number: NCT02191618
• Other Study ID Numbers: CP13-001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Microvention-Terumo, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Microvention-Terumo, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Microvention-Terumo, Inc.
• Verification Date: April 2020