A Medical Device to Treat Brain Aneurysms

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.

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Key information

Conditions

Cerebral Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Ivan Rilski University hospital, Sofia, Bulgaria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who present with intracranial aneurysm

Exclusion criteria

Unstable neurological deficit

Treatment and study plan

Nautilus endovascular device

Device

Patients will be treated with the Nautilus Endovascular device followed by treatment follow up for up to 6 months

Primary outcomes

Serious Adverse Events

Time frame: 3-6 months

The rate of participants experiencing death or stroke in treated vascular territory measured using the NIH stroke scale within 3- 6 months follow-up
Probable benefit

Time frame: 3-6 months

Rate of stable, successful aneurysm occlusion measured using the Raymond Roy Occlusion Classification at 3-6 months follow-up

Sponsors and collaborators

Lead sponsor

EndoStream Medical

Industry

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jul 15, 2021
Registry last updated: Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed