A Medical Device to Treat Brain Aneurysms

Cerebral Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04963933
• Other study ID #: CLD-262
• Status: Completed
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: July 2022
• Source: EndoStream Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 30, 2022
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who present with intracranial aneurysm

Exclusion Criteria:

• Unstable neurological deficit

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysm
• Intracranial Aneurysm

Intervention

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

Locations

Country	Name	City	State
Bulgaria	St. Ivan Rilski University hospital	Sofia
Latvia	Paula Stradina university hospital	Riga

Sponsors (1)

Lead Sponsor	Collaborator
EndoStream Medical

Countries where clinical trial is conducted

Bulgaria,  Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Events	The rate of participants experiencing death or stroke in treated vascular territory measured using the NIH stroke scale within 3- 6 months follow-up	3-6 months
Primary	Probable benefit	Rate of stable, successful aneurysm occlusion measured using the Raymond Roy Occlusion Classification at 3-6 months follow-up	3-6 months