N/A
N=152
Post Market Surveillance Study of the Wingspan Stent System
Intracranial Atherosclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02034058 ↗Enrolled (actual)
152
Serious AEs
5.9%
Results posted
Dec 2019
Primary outcome: Primary: Rate of Stroke or Death Among Participants — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Wingspan Stent System (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Stryker Neurovascular
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Stroke or Death Among Participants |
4 | — |
| SECONDARY Rate of Ischemic Stroke Among Participants |
1 | — |
| SECONDARY Rate of Neurological Death Among Participants |
2 | — |
| SECONDARY Rate of Stroke Recovery Among Participants |
— | — |
| SECONDARY Rate of Stroke in the Territory of the Stented Artery Among Participants |
4 | — |
Summary
The primary objective of this study is to evaluate the rate of stroke and/or death in patients treated with the Wingspan Stent System, according to the Indications for Use, within 72 hours post procedure.
Eligibility Criteria
All patients for whom treatment with the Wingspan Stent System is considered.
Data sourced from ClinicalTrials.gov (NCT02034058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.