NCT04963933

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

July 6, 2021

Last Update Submit

July 26, 2022

Conditions

Cerebral Aneurysm

Outcome Measures

Primary Outcomes (2)

  • 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

  • Probable benefit

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

    3-6 months

Study Arms (1)

Patients treated with the device

EXPERIMENTAL

Patients treated with the Nautilus will be followed up

Device: Nautilus endovascular device

Interventions

Nautilus endovascular deviceDEVICE

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

Patients treated with the device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \* Patients who present with intracranial aneurysm

You may not qualify if:

  • \* Unstable neurological deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Ivan Rilski University hospital

Sofia, 1431, Bulgaria

Location

Paula Stradina university hospital

Riga, LV-1002, Latvia

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 15, 2021

Study Start

March 17, 2021

Primary Completion

January 5, 2022

Study Completion

April 30, 2022

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

BU(1)LA(1)