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Mid-term Data Collection of the Treatment of Intracranial Aneurysms With the WEB™ Aneurysm Embolization System

NCT03379714 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2018-06-01

No results posted yet for this study

Summary

Flow disruption is a new endovascular approach for treatment of both ruptured and unruptured intracranial aneurysms, which involves placement of an endosaccular device (WEB) which modifies the blood flow at the level of the neck and induces intraaneurysmal thrombosis. The WEB was designed to treat wide-neck bifurcation aneurysms. This observational study will collect data about the routine practice in one center of using the WEB in ruptured and unruptured intracranial aneurysms. The primary objective is to evaluate its efficacy by assessing the anatomic outcome during follow-up.

Conditions

  • Ruptured and Unruptured Intracranial Aneurysms

Interventions

DEVICE

WEB aneurysm embolization system

The WEB aneurysm embolization system is a class III device and consists of an implantable embolization device attached to a delivery device. The WEB is a mesh composed of single layers of braided nitinol tubes with platinum cores. The braids are held together by proximal and distal platinum/ iridium radiopaque markers.

Sponsors & Collaborators

  • Archer Research

    collaborator INDUSTRY

  • Medical Therapy Solutions

    lead INDUSTRY

Principal Investigators

  • Maurits Voormolen, Prof Dr · Study Principal Investigator

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2021-12-31
Completion
2022-01-31

Countries

  • Belgium

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 NCT03379714 on ClinicalTrials.gov