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

NCT04839705 · tracked via the Priya Life Science USA tracker

Sponsor

Microvention-Terumo, Inc.

Phase

Not applicable

Started

2022-08-24

Last updated

2026-03-27

Condition(s) studied

Wide Neck Bifurcation Intracranial Aneurysms

Investigational drug(s) / intervention(s)

WEB

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Key Effectiveness Outcome — 12 Months
Proportion of subjects with adequate aneurysm occlusion at one year after treatment.
Key Safety Outcome — 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

Trial sites (27)

Facility	City	Region
Memorial Health Systems	Hollywood	Florida
Orlando Health Neuroscience Institute	Orlando	Florida
The Queen's Medical Center Neuroscience Institute	Honolulu	Hawaii
University of Iowa Hospitals and Clinics	Iowa City	Iowa
University of Kansas Health System	Kansas City	Kansas
Baptist Health Systems	Lexington	Kentucky
University of Kentucky, Department of Neurosurgery	Lexington	Kentucky
Norton Healthcare	Louisville	Kentucky
LSU Health Sciences Center at Shreveport	Shreveport	Louisiana
Johns Hopkins University	Baltimore	Maryland
Massachusetts General Brigham Incorporated	Boston	Massachusetts
UMass Memorial Health	Worcester	Massachusetts
Abbott Northwestern Hospital Allina Health	Minneapolis	Minnesota
The Washington University	St Louis	Missouri
Albany Medical Center	Albany	New York
University of Buffalo	Buffalo	New York
Northshore University Hospital/Northwell Health	Manhasset	New York
SUNY Stony Brook	Stony Brook	New York
Montefiore Medical Center	The Bronx	New York
Ohio State University	Columbus	Ohio
OhioHealth Research Institute	Columbus	Ohio
The Toledo Hospital d/b/a ProMedica Toledo Hospital	Toledo	Ohio
University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
University of Pennsylvania Health Systems	Philadelphia	Pennsylvania
Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
Semmes Murphey	Memphis	Tennessee
West Virginia University	Morgantown	West Virginia

More Microvention-Terumo, Inc. trials in the USA

Complex Aneurysm Registry - Real-World Evidence Data Collection Intracranial Aneurysm Treatment Devices Enrolling by invitation

MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study Active, not recruiting

Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04839705 on ClinicalTrials.gov ↗ ← All trials in the USA