RecruitingNot ApplicableNCT07225075

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

Sponsor

Balt USA

Enrollment

250 participants

Start Date

Feb 4, 2026

Study Type

INTERVENTIONAL

Conditions

Intracranial Aneurysm

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.

Eligibility

Min Age: 22 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Silk Vista Baby (SVB) Flow Diverter for people with intracranial aneurysm. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 22 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESilk 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.