Trials / Completed
CompletedNCT04518670
Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)
Success in Comaneci-assist Coils Embolization Surveillance Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 90 (actual)
- Sponsor
- Rapid Medical · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. A wide-necked intracranial aneurysm (IA) defines the neck width as ≥ 4 mm or a dome-to-neck ratio \< 2. The objective of the Postmarket Surveillance Plan is to assess safety and performance as used in postmarket clinical practice in the U.S.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Comaneci Embolization Assist Device | assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. |
Timeline
- Start date
- 2020-11-24
- Primary completion
- 2024-05-01
- Completion
- 2024-07-07
- First posted
- 2020-08-19
- Last updated
- 2026-01-21
- Results posted
- 2026-01-21
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04518670. Inclusion in this directory is not an endorsement.