Trials / Active Not Recruiting
Active Not RecruitingNCT04195568
Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System
EndoVascular Treatment Of Wide-Neck Aneurysms, an EvaLuation of Safety and EffectiVeness of Stryker Surpass Evolve™ Flow Diverter System
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 248 (actual)
- Sponsor
- Stryker Neurovascular · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the ICA or its branches
Detailed description
The Surpass Evolve Flow Diverter System is indicated for the endovascular treatment of adults (age 18 or above) with unruptured saccular wide-neck or fusiform intracranial aneurysms ≤ 12 mm for treatment in vessel diameters between 1.75-5.0mm.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Surpass Evolve Flow Diverter System | The Surpass Evolve Flow Diverter System is indicated for the endovascular treatment of adults (age 18 or above) with unruptured saccular wide-neck or fusiform intracranial aneurysms ≤12 mm. |
Timeline
- Start date
- 2020-07-07
- Primary completion
- 2025-07-14
- Completion
- 2028-09-13
- First posted
- 2019-12-12
- Last updated
- 2026-04-09
Locations
37 sites across 3 countries: United States, Australia, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04195568. Inclusion in this directory is not an endorsement.