A Medical Device to Treat Brain Aneurysms

EndoStream Medical

Status: Completed

Conditions: Cerebral Aneurysm

Treatments: Device: Nautilus endovascular device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04963933

CLD-262

Details and patient eligibility

About

An aneurysm is a bulge in a blood vessel caused by a weakness in the blood vessel wall, usually where it branches. As blood passes through the weakened blood vessel, the blood pressure causes a small area to bulge outwards like a balloon. Most brain aneurysms only cause noticeable symptoms if they burst (rupture). This leads to an extremely serious condition known as a subarachnoid hemorrhage, where bleeding caused by the ruptured aneurysm can cause extensive brain damage and symptoms.

The study aims to evaluate the safety and effectiveness of a medical device to treat brain aneurysms.

Full description

Patients will be treated with the Nautilus, then will be followed up for up to 6 months.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

* Patients who present with intracranial aneurysm

Exclusion criteria

* Unstable neurological deficit

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Patients treated with the device

Experimental group

Description:

Patients treated with the Nautilus will be followed up

Treatment:

Device: Nautilus endovascular device