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

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

PI/Lead Researcher: Varun Naragum, MD

IRB#: 2430258

NCT#: NCT07225075

Location: Baystate Medical Center

Primary Sponsor: BALT USA, LLC

Purpose: The purpose of this study is to assess the safety and efficacy of the Silk Vista Baby (SVB) Flow Diverter in the treatment of unruptured aneurysms originating from parent vessels at or beyond the level of the internal carotid artery (ICA) terminus, in SVB-amenable anterior and posterior circulation anatomy.

Eligibility

Inclusion Criteria:

  • Age 22 to ≤ 80 years old.
  • Participant has a single target unruptured intracranial aneurysm (IA) originating from a parent vessel of 1.5 mm to 3.4mm in diameter located at or distal to the ICA terminus or in SVB-amenable anterior or posterior anatomy.
  • Participant has a target saccular or fusiform IA with an aneurysm neck ≥ 4mm or a dome to neck ratio <2.

Exclusion Criteria:

  • Target aneurysm is unsuitable for flow diverter treatment.
  • Has vessel characteristics, such as severe tortuosity, stenosis, atherosclerotic disease, or morphology that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device.
  • Major surgery (including previous intracranial implant) occurred within previous 30 days or is planned in the next 120 days after treatment date
  • Chronic anticoagulation therapy is ongoing or known coagulopathy exists
  • Has other known serious concurrent medical conditions, such as active bacterial infection, heart disease (including atrial fibrillation, pacemaker, recent myocardial infarction [< 12 weeks], symptomatic congestive heart failure, or carotid stenosis), kidney failure [e.g., >2.0mg/dl serum creatinine] or any other non-neurological disease-related acute life-threatening illness to be treated in this trial, pulmonary disease, uncontrolled diabetes, progressive neurologic disorders, cancer requiring active treatment (e.g., chemotherapy, etc.) or on palliative care, vasculitis, high risk of ischemic stroke or recent stroke (within 30 days)
  • Women who are pregnant or nursing at the time of enrollment or women who wish to become pregnant during the length of study participation

Dates and Time Commitment

Recruitment Status: Active, Recruiting

Active Date Opened to Enrollment/Recruitment: 08/17/2026

Trial Start Date: 02/04/2026
Trial Expire Date: 02/01/2031
Time Commitment: 2 years

Contact 

Contact Name: Clinical Trials Unit
Contact Phone: (413) 794-6690
Contact Email: ctu.staff@baystatehealth.org

 

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