Trials / Completed
CompletedNCT01778322
WEB Clinical Assessment of IntraSaccular Aneurysm Therapy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 51 (actual)
- Sponsor
- Microvention-Terumo, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms
Detailed description
The following parameters will be evaluated as part of this study: * Aneurysm morphology * Aneurysm size * For ruptured aneurysms: Hunt and Hess Classification of Subarachnoid Hemorrhage (SAH) * Size of the embolization device(s) used in the procedure * Intra-procedural assessment of aneurysm occlusion and flow stasis * Degree of aneurysm occlusion post-procedure (percentage occlusion, Raymond Scale and other scores as appropriate) * Aneurysm occlusion durability * Recanalization rate * Device-related changes in Modified Rankin Scale from baseline * Complications/adverse events * Rebleed/new bleed
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Intracranial aneurysm embolization | Treatment of intracranial aneurysms |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2015-12-01
- Completion
- 2019-12-01
- First posted
- 2013-01-29
- Last updated
- 2023-03-15
Locations
12 sites across 4 countries: Denmark, France, Germany, Hungary
Source: ClinicalTrials.gov record NCT01778322. Inclusion in this directory is not an endorsement.