A Medical Device to Treat Brain Aneurysms

Not Applicable

Completed

• Conditions: Cerebral Aneurysm

• Registration Number: NCT04963933
• Lead Sponsor: EndoStream Medical

Brief 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.

Study Timeline

• Study Start: 2021-03-17
• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-15
• Primary Completion: 2022-01-05
• Study Completion: 2022-04-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

* Patients who present with intracranial aneurysm

Exclusion Criteria

* Unstable neurological deficit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Probable benefit	3-6 months	Rate of stable, successful aneurysm occlusion measured using the Raymond Roy Occlusion Classification at 3-6 months follow-up
Serious Adverse Events	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

Trial Locations

Locations (2)

St. Ivan Rilski University hospital; 🇧🇬 Sofia, Bulgaria

Paula Stradina university hospital; 🇱🇻 Riga, Latvia