Trials / Completed
CompletedNCT02609867
A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)
A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of 'Flowise Cerebral Flow Diverter' for the Treatment of Unruptured Wide-necked Cerebral Aneurysm in the Internal Carotid Artery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Yonsei University · Academic / Other
- Sex
- All
- Age
- 19 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of 'Flowise Cerebral Flow Diverter' for the treatment of unruptured wide-necked cerebral aneurysm in the internal carotid artery.
Detailed description
Flowise is indicated for use in patients with unruptured wide-necked aneurysm in the internal carotid artery. Consecutive subject data should be collected at discharge, 1, 3, and 6 month post Flowise implantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Flowise Cerebral Flow Diverter | Flowise Cerebral Flow Diverter Placement |
Timeline
- Start date
- 2015-10-23
- Primary completion
- 2018-01-22
- Completion
- 2018-01-22
- First posted
- 2015-11-20
- Last updated
- 2019-07-05
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02609867. Inclusion in this directory is not an endorsement.