Treatment of Ruptured and Unruptured Wide-Neck Aneurysms With Nautilus™ Device Assisted Occlusion (TORNADO)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 4
- Primary Endpoint
- Probable benefit
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •* Patients who present with intracranial aneurysm
Exclusion Criteria
- •* Unstable neurological deficit
Outcomes
Primary Outcomes
Probable benefit
Time Frame: 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
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported