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Long-term safety of the WEB device for wide-neck brain aneurysms

Tests the WEB device in adults with wide neck bifurcation brain aneurysms.

Key facts

Who runs it
Microvention-Terumo, Inc.
Where
Albany, Baltimore, Boston, Buffalo, Columbus, Durham, Hollywood, Honolulu, Iowa City, Kansas City, Lexington, Louisville, Manhasset, Memphis, Minneapolis, Morgantown, Oklahoma City, Orlando, Philadelphia, Shreveport, St Louis, Stony Brook, The Bronx, Toledo, and Worcester, United StatesSee the 29 sites
Trial code
Registry title
Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Status
Recruiting
People taking part
200 people, planned
Started
24 Aug 2022
Expected to end
7 May 2031
Type of study
Interventional
Treatments tested
  • WEB
Record updated
10 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with one wide-neck bifurcation aneurysm in the brain that needs treatment. The aneurysm may have burst or not. It will be treated with the WEB device.

Age
18 years or older
Sex
All sexes
Disease stage
A single brain aneurysm, burst (ruptured) or not burst, that needs treatment. It can be in the front or back blood supply of the brain.
Earlier treatment
The aneurysm being studied must not have been treated before.

Main reasons for not taking part

  • The aneurysm cannot be treated from inside the blood vessels.
  • High risk of stroke, or a mini-stroke or stroke in the past 30 days.
  • Bleeding in the brain from another aneurysm or another cause in the past 90 days.
  • The aneurysm was treated before.
  • Pregnancy.

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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 IRB-approved written informed consent prior to initiation of any study procedures

Who cannot take part

  • 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's index IA was previously treated
  • Patient has had an SAH from a non-index IA or any other intracranial hemorrhage within 90 days
  • Patient has an IA with characteristics unsuitable for endovascular treatment
  • Patient is pregnant

Where in United States

  • Albany Medical CenterAlbany, United StatesContact: Julia ZajaceskowskiTaking people
  • Johns Hopkins UniversityBaltimore, United StatesContact: Rachael EddowesTaking people
  • University of Maryland, BaltimoreBaltimore, United StatesContact: Robert GashNo longer taking part
  • Massachusetts General Brigham IncorporatedBoston, United StatesContact: Shayna HollanderTaking people
  • University of BuffaloBuffalo, United StatesContact: Eric MillerTaking people
  • Ohio State UniversityColumbus, United StatesContact: Edouard BelizaireTaking people
  • OhioHealth Research InstituteColumbus, United StatesContact: Marissa MosherTaking people
  • Duke UniversityDurham, United StatesContact: Robert GashNo longer taking part
  • Memorial Health SystemsHollywood, United StatesContact: Piret BaldwinTaking people
  • The Queen's Medical Center Neuroscience InstituteHonolulu, United StatesContact: Kelly DiedrichTaking people
  • University of Iowa Hospitals and ClinicsIowa City, United StatesContact: Heena OlaldeTaking people
  • University of Kansas Health SystemKansas City, United StatesContact: Max HardenbrookTaking people
  • Baptist Health SystemsLexington, United StatesContact: Candice BruntonTaking people
  • University of Kentucky, Department of NeurosurgeryLexington, United StatesContact: Rachel NorrisTaking people
  • Norton HealthcareLouisville, United StatesContact: Trina DeForrestTaking people
  • Northshore University Hospital/Northwell HealthManhasset, United StatesContact: Stanislav OstrovskiTaking people
  • Semmes MurpheyMemphis, United StatesContact: Amira KingTaking people
  • Abbott Northwestern Hospital Allina HealthMinneapolis, United StatesContact: Nimco EssaTaking people
  • West Virginia UniversityMorgantown, United StatesContact: Jennifer DomicoTaking people
  • University of Oklahoma Health Sciences CenterOklahoma City, United StatesContact: Michael OminiTaking people
  • Orlando Health Neuroscience InstituteOrlando, United StatesContact: Thomas MelendezTaking people
  • Thomas Jefferson University HospitalPhiladelphia, United StatesContact: Sha'Mere HerderTaking people
  • University of Pennsylvania Health SystemsPhiladelphia, United StatesContact: Inhye HwangTaking people
  • LSU Health Sciences Center at ShreveportShreveport, United StatesContact: Annabeth PiroTaking people
  • The Washington UniversitySt Louis, United StatesContact: Ramie HeoTaking people
  • SUNY-Stony BrookStony Brook, United StatesContact: Dawn MadiganTaking people
  • Montefiore Medical CenterThe Bronx, United StatesContact: Lavinia WilliamsTaking people
  • The Toledo Hospital d/b/a ProMedica Toledo HospitalToledo, United StatesContact: Jennifer DuraTaking people
  • UMASS Memorial HealthWorcester, United StatesContact: Noelle BodkinTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • WEB Aneurysm Embolization DeviceOther group

    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.

    Treatment: WEB

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Plain-language title
Long-term safety of the WEB device for wide-neck brain aneurysmsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
10 November 2026