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

NCT04839705 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2026-03-27

No results posted yet for this 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.

Conditions

  • Wide Neck Bifurcation Intracranial Aneurysms

Interventions

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

Sponsors & Collaborators

  • Microvention-Terumo, Inc.

    lead INDUSTRY

Principal Investigators

  • David Fiorella, MD · Stony Brook University, Stony Brook NY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-24
Primary Completion
2026-05-31
Completion
2030-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04839705 on ClinicalTrials.gov