Trials / Completed
CompletedNCT04106583
Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities
A Prospective, Multicenter Study Assessing the Embolization of Intracranial Aneurysms Using WAVE™ Extra Soft Coils, a Part of the Penumbra SMART COIL® System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 572 (actual)
- Sponsor
- Penumbra Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to demonstrate the safety and efficacy of the Penumbra SMART COIL® System, including the WAVE™ Extra Soft Coils (WAVE) as a fill and finish coil, in the treatment of intracranial aneurysms. Imaging will be analyzed by an independent core lab to assess aneurysm occlusion rates and perform a comparative analysis between imaging modalities.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | WAVE, as part of the SMART COIL System | WAVE, as part of the SMART COIL System |
Timeline
- Start date
- 2019-11-05
- Primary completion
- 2023-08-02
- Completion
- 2023-08-02
- First posted
- 2019-09-27
- Last updated
- 2025-03-04
- Results posted
- 2025-03-04
Locations
43 sites across 6 countries: United States, Canada, Germany, Italy, Spain, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04106583. Inclusion in this directory is not an endorsement.