No phaseRecruiting
Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER)
- Sponsor
- Balt USA (Industry)
- Enrolment
- 250 planned
- Conditions
- Intracranial Aneurysm
- Interventions
- Silk Vista Baby (SVB) Flow Diverter
- Ages
- adults, older adults
- Registry
- NCT07225075
From the registry
The PIONEER Study is a pivotal, multi-center, prospective, single-arm study designed to evaluate the safety and efficacy of the Silk Vista Baby (SVB) Flow Diverter for the treatment of unruptured aneurysms.
Primary outcomes
- Proportion of participants with complete occlusion of the treated IA based on the Raymond-Roy I classification without significant parent artery stenosis (>50%), as evaluated by an independent Core Lab, without retreatment of the target aneurysm