NCT04963933

A Medical Device to Treat Brain Aneurysms

Treatment of Ruptured and Unruptured Wide-Neck Aneurysms With Nautilus™ Device Assisted Occlusion (TORNADO)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: EndoStream Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Cerebral Aneurysm

Interventions

Type	Name	Description
DEVICE	Nautilus endovascular device	Patients will be treated with the Nautilus Endovascular device followed by treatment follow up for up to 6 months

Timeline

• Start date: 2021-03-17
• Primary completion: 2022-01-05
• Completion: 2022-04-30
• First posted: 2021-07-15
• Last updated: 2022-07-27

Locations

2 sites across 2 countries: Bulgaria, Latvia