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

Part of paid clinical trials in Thousand Oaks, California.

Sponsor
Balt USA
Study ID
NCT07225075
Status
Recruiting
Apply to this trial

Conditions

  • Intracranial Aneurysm

Eligibility Criteria

Sex
ALL
Age
22 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Silk Vista Baby (SVB) Flow Diverter — DEVICE
    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.

Study Details

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 Dates

First listed
Nov 5, 2025
Start date
Feb 4, 2026
Status verified
Jul 2026
Primary completion
Feb 28, 2030
Completion
Feb 28, 2031

Study Design

Enrollment
250 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Silk Vista Baby (SVB) Flow Diverter
    Participants meeting eligibility criteria will undergo endovascular treatment of a single unruptured intracranial aneurysm using the SVB Flow Diverter.

Primary Outcome Measure

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 [ Time Frame: 1 year post procedure ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Vascular and Neuroscience Institute of Southern CaliforniaThousand OaksCalifornia91360
Priya Kaushal
Baptist HealthJacksonvilleFlorida32207
Teresa Nicol

Find similar trials in Thousand Oaks, CA

By research site
Vascular and Neuroscience Institute of Southern California· Thousand Oaks, CABaptist Health· Jacksonville, FL

Related Studies