Evaluating the long-term safety and effectiveness of the WEB device for treating wide neck bifurcation intracranial aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to assess the long-term safety and effectiveness of the WEB device in treating wide neck bifurcation intracranial aneurysms in adult patients. It is a prospective, multicenter, single-arm study that will evaluate the adequacy of aneurysm occlusion one year after treatment, as determined by a core laboratory. Participants will include adults with either ruptured or unruptured aneurysms requiring treatment, and they will be monitored for safety and effectiveness outcomes over time.

Why it matters

Who can join: the full rules

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 IRB-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 any other intracranial hemorrhage within 90 days
* Patient's index IA was previously treated
* Patient is pregnant

Where it's running

• Memorial Health Systems
  Hollywood, Florida, United States Recruiting
• Orlando Health Neuroscience Institute
  Orlando, Florida, United States Recruiting
• The Queen's Medical Center Neuroscience Institute
  Honolulu, Hawaii, United States Recruiting
• University of Iowa Hospitals and Clinics
  Iowa City, Iowa, United States Recruiting
• University of Kansas Health System
  Kansas City, Kansas, United States Recruiting
• Baptist Health Systems
  Lexington, Kentucky, United States Recruiting

Study contacts

• Principal investigator: David Fiorella, MD — Stony Brook University, Stony Brook NY
• Study coordinator: Robert Gash
• Email: robert.gash@terumo.com
• Phone: 908-914-1045

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing WEB and other treatments for ruptured aneurysms

  This study is testing whether a new device called WEB works better than other treatments for people with ruptured brain aneurysms.

  Recruiting Microvention-Terumo, Inc. · Reims · NCT06511245

• Collecting real-life data on endovascular treatments for brain aneurysms

  This study is collecting real-life information on how safe and effective a specific type of device is for treating brain aneurysms in patients.

  Recruiting Microvention-Terumo, Inc. · Vigo, Pontevedra · NCT06494436

• Real-world outcomes of MicroVention devices for intracranial aneurysm treatment

  This project collects real-world data to see how well commercially available MicroVention devices work for treating brain aneurysms in patients treated by their doctors.

  Recruiting at 27 sites Microvention-Terumo, Inc. · Walnut Creek, California and 26 other locations · NCT06215105

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.