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

Medical Therapy Solutions

Status: Terminated

Conditions: Ruptured and Unruptured Intracranial Aneurysms

Treatments: Device: WEB aneurysm embolization system

Study type: Observational

Funder types: Industry

Identifiers

NCT03312725

MTS-01

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1 participants in 1 patient group

Patients with ruptured or unruptured intracranial aneurysms.

Treatment:

Device: WEB aneurysm embolization system