Trials / Completed
CompletedNCT03611790
Vesalio NeVa VS for Symptomatic Cerebral Vasospasm Following aSAH (The VITAL Study)
The Vesalio Neva VS for the Treatment of Symptomatic Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage (aSAH) (The VITAL Study)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Vesalio · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to assess the safety and probable benefit of the Neva VS device in patients presenting with symptomatic cerebral vasospasm despite maximal medical management following aSAH.
Detailed description
This is a prospective, open label, single-arm study. Up to 30 eligible subjects at up to 15 sites will participate in the study. Subjects will be followed up for 30 days post-intervention.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NeVa VS | mechanical dilatation |
Timeline
- Start date
- 2018-12-19
- Primary completion
- 2021-05-31
- Completion
- 2021-05-31
- First posted
- 2018-08-02
- Last updated
- 2023-01-03
- Results posted
- 2023-01-03
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03611790. Inclusion in this directory is not an endorsement.