Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
WEB PAS
Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device
1 other identifier
interventional
195
1 country
27
Brief Summary
A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2021
CompletedFirst Posted
Study publicly available on registry
April 9, 2021
CompletedStudy Start
First participant enrolled
August 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
ExpectedMarch 27, 2026
March 1, 2026
3.7 years
April 7, 2021
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Key Effectiveness Outcome
Proportion of subjects with adequate aneurysm occlusion at one year after treatment.
12 Months
Key Safety Outcome
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
12 Months
Study Arms (1)
WEB Aneurysm Embolization Device
OTHERWEB 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.
Interventions
Device: WEB The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. Other Names: • WEB Aneurysm Embolization Device
Eligibility Criteria
You may qualify if:
- Patient must be ≥ 18 at the time of screening
- Patient must have a single ruptured or unruptured IA requiring treatment
- Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures
You may not qualify if:
- Patient has an IA with characteristics unsuitable for endovascular treatment
- Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
- Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days
- Patient index IA was previously treated
- Patient is pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Memorial Health Systems
Hollywood, Florida, 33021, United States
Orlando Health Neuroscience Institute
Orlando, Florida, 32806, United States
The Queen's Medical Center Neuroscience Institute
Honolulu, Hawaii, 96813, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Health System
Kansas City, Kansas, 66160, United States
Baptist Health Systems
Lexington, Kentucky, 40503, United States
University of Kentucky, Department of Neurosurgery
Lexington, Kentucky, 40536, United States
Norton Healthcare
Louisville, Kentucky, 40241, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Massachusetts General Brigham Incorporated
Boston, Massachusetts, 02114, United States
UMass Memorial Health
Worcester, Massachusetts, 01655, United States
Abbott Northwestern Hospital Allina Health
Minneapolis, Minnesota, 55407, United States
The Washington University
St Louis, Missouri, 63110, United States
Albany Medical Center
Albany, New York, 12208, United States
University of Buffalo
Buffalo, New York, 14203, United States
Northshore University Hospital/Northwell Health
Manhasset, New York, 11030, United States
SUNY Stony Brook
Stony Brook, New York, 11794, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Ohio State University
Columbus, Ohio, 43210, United States
OhioHealth Research Institute
Columbus, Ohio, 43214, United States
The Toledo Hospital d/b/a ProMedica Toledo Hospital
Toledo, Ohio, 43606, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Semmes Murphey
Memphis, Tennessee, 38120, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Fiorella, MD
Stony Brook University, Stony Brook NY
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2021
First Posted
April 9, 2021
Study Start
August 24, 2022
Primary Completion
May 1, 2026
Study Completion (Estimated)
May 1, 2030
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share