TerminatedNot Applicable

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

Stopped: Sponsor decision

Belgium1 participantsStarted 2017-02-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient is between 18 and 80 years old. * Patient must sign and date the informed consent form \<72hrs post-procedure and prior to data registration. If patient is not able to give informed consent for himself/herself, a legally authorized representative must give informed consent on his/her behalf. * Patient has a ruptured (Hunt and Hess grades 1, 2 or 3) or unruptured intracranial aneurysm requiring endovascular treatment. * Aneurysm with dome-to-neck ratio ≥ 1. Exclusion Criteria: * Aneurysm size unfavourable for WEB implantation (aneurysm width \> 10 mm or aneurysm width \< 3mm). * Patient with Hunt and Hess grades 4 or 5. * Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history). * Parent vessel occlusion.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determination of anatomic outcome: grade of occlusion of the aneurysm assessed by MRA

Timeframe: at 6 months follow-up

Determination of anatomic outcome: grade of occlusion of the aneurysm assessed by MRA

Timeframe: at 24 months follow-up

Trial details

NCT IDNCT03312725

SponsorMedical Therapy Solutions

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-06-26

View on ClinicalTrials.gov More Ruptured and Unruptured Intracranial Aneurysms trials