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The WEB-IT Clinical Study

NCT02191618 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-12-27

Study results available
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Summary

The study is a prospective, multicenter single-arm cohort. Patients with wide neck bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular treatment. In this study, all patients with qualifying WNBAs will be treated with the WEB. The primary effectiveness outcome of the study is the likelihood of complete intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

Conditions

  • Wide Neck Bifurcation Intracranial Aneurysms
  • Intracranial Aneurysms

Interventions

DEVICE

WEB

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

Sponsors & Collaborators

  • Microvention-Terumo, Inc.

    lead INDUSTRY

Principal Investigators

  • Adam Arthur, MD · Methodist University Hospital, Memphis, TN

  • 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
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2017-09-30
Completion
2023-06-30

Countries

  • United States
  • Canada
  • Denmark
  • Germany
  • Hungary
  • Turkey (Türkiye)

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 NCT02191618 on ClinicalTrials.gov