Back to resultsA Medical Device to Treat Brain Aneurysms
Primary Purpose
Cerebral Aneurysm
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Nautilus endovascular device
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Aneurysm
Eligibility Criteria
Inclusion Criteria:
* Patients who present with intracranial aneurysm
Exclusion Criteria:
* Unstable neurological deficit
Sites / Locations
- St. Ivan Rilski University hospital
- Paula Stradina university hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients treated with the device
Arm Description
Patients treated with the Nautilus will be followed up
Outcomes
Primary Outcome Measures
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
Probable benefit
Rate of stable, successful aneurysm occlusion measured using the Raymond Roy Occlusion Classification at 3-6 months follow-up
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04963933
Brief Title
A Medical Device to Treat Brain Aneurysms
Official Title
Treatment of Ruptured and Unruptured Wide-Neck Aneurysms With Nautilus™ Device Assisted Occlusion (TORNADO)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
January 5, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EndoStream Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
Detailed Description
Patients will be treated with the Nautilus, then will be followed up for up to 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients treated with the device
Arm Type
Experimental
Arm Description
Patients treated with the Nautilus will be followed up
Intervention Type
Device
Intervention Name(s)
Nautilus endovascular device
Intervention Description
Patients will be treated with the Nautilus Endovascular device followed by treatment follow up for up to 6 months
Primary Outcome Measure Information:
Title
Serious Adverse Events
Description
The rate of participants experiencing death or stroke in treated vascular territory measured using the NIH stroke scale within 3- 6 months follow-up
Time Frame
3-6 months
Title
Probable benefit
Description
Rate of stable, successful aneurysm occlusion measured using the Raymond Roy Occlusion Classification at 3-6 months follow-up
Time Frame
3-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
* Patients who present with intracranial aneurysm
Exclusion Criteria:
* Unstable neurological deficit
Facility Information:
Facility Name
St. Ivan Rilski University hospital
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Paula Stradina university hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Medical Device to Treat Brain Aneurysms
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