WithdrawnNot Applicable

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

Stopped: Sponsor decision

Belgium0Started 2018-01-01

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 range18 Years

SexALL

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Inclusion criteria

✓. Patient is at least 18 years old.
✓. Patient is capable to undergo general anaesthesia.
✓. Patient must sign and date the informed consent form 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 or unruptured intracranial aneurysm requiring endovascular treatment.
✓. Aneurysm with dome-to-neck ratio ≥ 1.
✓. Aneurysm size favourable for WEB implantation (aneurysm width \< 10 mm or aneurysm width \> 3mm).

Exclusion criteria

✕. Patient is pregnant.
✕. Patient has renal insufficiency (GRF \< 45 ml/min/1.73 m2).
✕. Patient is unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).

What they're measuring

Determination of anatomic outcome

Timeframe: at 6 months

Determination of anatomic outcome

Timeframe: at 24 months

Trial details

NCT IDNCT03379714

SponsorMedical Therapy Solutions

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-12-31

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