A Medical Device to Treat Brain Aneurysms

Sponsor
EndoStream Medical (Industry)
Overall Status
Completed
CT.gov ID
NCT04963933
Collaborator
(none)
30
2
1
13.4
15
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Nautilus endovascular device
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Ruptured and Unruptured Wide-Neck Aneurysms With Nautilus™ Device Assisted Occlusion (TORNADO)
Actual Study Start Date :
Mar 17, 2021
Actual Primary Completion Date :
Jan 5, 2022
Actual Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients treated with the device

Patients treated with the Nautilus will be followed up

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Probable benefit [3-6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients who present with intracranial aneurysm
Exclusion Criteria:
  • Unstable neurological deficit

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Ivan Rilski University hospital Sofia Bulgaria 1431
2 Paula Stradina university hospital Riga Latvia LV-1002

Sponsors and Collaborators

  • EndoStream Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EndoStream Medical
ClinicalTrials.gov Identifier:
NCT04963933
Other Study ID Numbers:
  • CLD-262
First Posted:
Jul 15, 2021
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022