Clinical Trial

Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER)

Study acronym: PIONEER
Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 7 changes
critical Trial status changed: Withheld → Recruiting 2026-07-19
critical Phase changed: not specified -> not applicable 2026-07-19
critical Primary endpoint(s) modified 2026-07-19
notable Enrollment changed: None -> 250 2026-07-19
notable Sponsor changed: [Redacted] -> Balt USA 2026-07-19
minor Trial arms changed: 0 -> 1 2026-07-19
notable Trial sites expanded: 0 -> 3 locations 2026-07-19
Trial Details
NCT Number NCT07225075
Lead Sponsor Balt USA
Conditions Intracranial Aneurysm
Enrollment 250 participants
Start Date 2026-02-04
Primary Completion 2030-02 (estimated)
Study Completion 2031-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-17