Trials / Active Not Recruiting
Active Not RecruitingNCT04839705
Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 195 (estimated)
- Sponsor
- Microvention-Terumo, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | WEB | Device: WEB The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. Other Names: • WEB Aneurysm Embolization Device |
Timeline
- Start date
- 2022-08-24
- Primary completion
- 2026-05-01
- Completion
- 2030-05-01
- First posted
- 2021-04-09
- Last updated
- 2026-03-27
Locations
27 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04839705. Inclusion in this directory is not an endorsement.