PIONEER Study: Silk Vista Baby Flow Diverters for Unruptured Intracranial Aneurysms
This study, called PIONEER, is testing a device called the Silk Vista Baby (SVB) Flow Diverter. This device is used to treat unruptured intracranial aneurysms (a weak, bulging spot in a blood vessel in the brain that hasn't burst yet). The study aims to see how safe and effective the SVB Flow Diverter is for adults aged 22 to 80 who have certain types of unruptured aneurysms. Success in this study means that the aneurysm is completely closed off one year after the procedure, without significant narrowing of the main artery or needing another treatment. The current status of this study is unclear, and it plans to enroll 250 participants.
- Study design
- This is a pivotal, multi-center, prospective, single-arm study, meaning all participants receive the same treatment. It plans to enroll 250 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least one year after the procedure to check for complete aneurysm closure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER)
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Ricardo Hanel, MD. PhD · PRINCIPAL_INVESTIGATOR · Baptist Medical Center Jacksonville
- Vitor M Pereira, MD, MSc · PRINCIPAL_INVESTIGATOR · St. Michael's Hospital/Unity Health
Who to contact
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What this trial measures
- 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 aneurysm1 year post procedure