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RECRUITING
NCT07225075
NA

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

Sponsor: Balt USA

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.

Key Details

Gender

All

Age Range

22 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2026-02-04

Completion Date

2031-02

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

DEVICE

Silk Vista Baby (SVB) Flow Diverter

The Silk Vista Baby (SVB) flow diverter is indicated for use in the endovascular treatment of adults (22 years of age and older) with unruptured small or medium (≤12mm) wide-neck (neck width ≥ 4mm or dome-to-neck ratio \< 2), saccular or fusiform, intracranial aneurysms at or distal to the ICA terminus, in SVB-amenable anterior and posterior anatomy arising from a parent vessel with a minimum diameter of 1.5mm and a maximum diameter of 3.4mm.

Locations (5)

Vascular and Neuroscience Institute of Southern California

Thousand Oaks, California, United States

John Muir Health - Walnut Creek Hospital

Walnut Creek, California, United States

Baptist Health

Jacksonville, Florida, United States

Baystate Medical Center

Springfield, Massachusetts, United States

St. Michael's Hospital/Unity Health

Toronto, Ontario, Canada