Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device (WEB PAS)

March 23, 2026 updated by: Microvention-Terumo, Inc.

Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

195

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Health Systems
      • Orlando, Florida, United States, 32806
        • Orlando Health Neuroscience Institute
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queen's Medical Center Neuroscience Institute
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Health System
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Systems
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky, Department of Neurosurgery
      • Louisville, Kentucky, United States, 40241
        • Norton Healthcare
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Sciences Center at Shreveport
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Brigham Incorporated
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Health
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital Allina Health
    • Missouri
      • St Louis, Missouri, United States, 63110
        • The Washington University
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Buffalo, New York, United States, 14203
        • University of Buffalo
      • Manhasset, New York, United States, 11030
        • Northshore University Hospital/Northwell Health
      • Stony Brook, New York, United States, 11794
        • SUNY Stony Brook
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
      • Columbus, Ohio, United States, 43214
        • OhioHealth Research Institute
      • Toledo, Ohio, United States, 43606
        • The Toledo Hospital d/b/a ProMedica Toledo Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health Systems
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Semmes Murphey
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: WEB Aneurysm Embolization Device
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

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

Other Names:

• WEB Aneurysm Embolization Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Key Effectiveness Outcome
Time Frame: 12 Months
Proportion of subjects with adequate aneurysm occlusion at one year after treatment.
12 Months
Key Safety Outcome
Time Frame: 12 Months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Microvention-Terumo, Inc.

Investigators

  • Principal Investigator: David Fiorella, MD, Stony Brook University, Stony Brook NY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2022

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL11010-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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