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

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.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Silk Vista Baby (SVB) Flow Diverter

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gregory Tirrell; Phone Number: 949-788-1443; Email: gregory.tirrell@baltgroup.com
• Study Contact Backup: Name: Richelle Massey; Email: richelle.massey@baltgroup.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 1R6
      • Recruiting
      • St. Michael's Hospital/Unity Health
      • Contact: Eileen Liu
• United States
  • California
    • Thousand Oaks, California, United States, 91360
      • Recruiting
      • Vascular and Neuroscience Institute of Southern California
      • Contact: Priya Kaushal
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Baptist Health
      • Contact: Teresa Nicol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 22 to ≤ 80 years old
2. 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
3. Participant has a target saccular or fusiform IA with an aneurysm neck ≥ 4mm or a dome to neck ratio <2
4. Participant has a target IA that is ≤ 12 mm
5. Participant meets one or more risk factors for IA rupture, such as age (≤70); hypertension; cigarette smoking; use of sympathomimetic drugs; Japanese or Finnish ancestry; history of prior aneurysmal subarachnoid hemorrhage (aSAH); familial intracranial aneurysms or SAH; clinical or radiological mass effect; reduced quality of life due to fear of rupture; IA size, location, and morphology (yielding 1 point or greater score per UIATS scale); documented growth of IA on serial imaging; presence of multiple IAs; and presence of concurrent pathology
6. Participant has pre-procedure (obtained up to 14 days prior to the procedure day) PRU value between 60-200
7. Participant or a legally authorized representative (LAR) provides written informed consent using the IRB/REB-approved consent form and agrees to comply with protocol follow-up and requirements

Exclusion Criteria:

1. Target aneurysm is unsuitable for flow diverter treatment
2. Subject requires more than one flow diverter for target aneurysm treatment
3. 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
4. Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
5. Has a medical contraindication to study or procedure-related antiplatelet/anticoagulation medications (e.g., aspirin, clopidogrel/Plavix, ticagrelor, Prasugrel, Gp IIb/IIIa inhibitors, heparin, etc.), local or general anesthesia, or life-threatening allergy to contrast dye
6. Has a known severe allergy to nickel, titanium or platinum
7. Modified Rankin Score (mRS) assessment is ≥ 3 at screening or pre-procedure mRS could not be assessed
8. The health of the participant or the validity of the study outcomes (e.g., high risk of neurologic events, worsening of clinical condition in the last 30 days) may be compromised by the participant's enrollment
9. Subarachnoid hemorrhage occurred within 30 days prior to enrollment
10. Intracranial parenchymal hemorrhage occurred within 60 days prior to enrollment
11. Major surgery (including previous intracranial implant) occurred within previous 30 days or is planned in the next 120 days after treatment date
12. Has more than one IA that requires treatment within 120 days of treatment date
13. Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 12 weeks prior to treatment date
14. Requires adjunctive coiling during SVB procedure
15. Chronic anticoagulation therapy is ongoing or known coagulopathy exists
16. 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)
17. Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)
18. Unable to complete study follow-up due to dementia or psychiatric disorder, substance abuse, or history of noncompliance with medical advice
19. Women who are pregnant or nursing at the time of enrollment or women who wish to become pregnant during the length of study participation
20. Presence of intracranial mass (tumor, except meningioma that doesn't require surgery for 1 year) or non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
21. Participation in any other investigational study which can influence collection of valid data under this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	1 year post procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Complete occlusion of the treated aneurysm using the Raymond-Roy scale without significant parent artery stenosis (>50%), as adjudicated by an independent Core Lab, without retreatment of target IA	180 days and 2 years post-procedure
Complete occlusion of the treated aneurysm using the O'Kelly Marotta scale without significant parent artery stenosis (>50%), as adjudicated by an independent Core Lab, without retreatment of the target IA	180 days, 1 year, and 2 years post-procedure
Clinically acceptable occlusion of the treated aneurysm using the Raymond-Roy scale without significant parent artery stenosis (>50%) as adjudicated by an independent Core Lab, without retreatment of the target IA	Within 180 days, 1 year, and 2 years post procedure
Unplanned alternative treatment of the target IA	Within 1 year post procedure
Device deployment success rate	Index procedure
Device migration rate	180 days, 1 year, and 2 years post procedure
Evolution of occlusion between post-procedure and timepoints listed under timeframe, as adjudicated by an independent Core Lab	1 year and 2 years post procedure
Occurrence of parent artery occlusion	1 year and 2 years post procedure
Occurrence of >50% In-Stent Stenosis at the target IA	1 year and 2 years post procedure

Other Outcome Measures

Outcome Measure	Time Frame
AEs will be analyzed with a specific summary rate of intracranial hemorrhage, ischemic stroke, all cause mortality including neurological death as adjudicated by the CEC	30 days, 180 days, 1 year, and 2 years post procedure
Occurrence of all SVB device and/or procedure related AEs	30 days, 180 days, 1 year, and 2 years post procedure
Proportion of participants with no change, improvement, or deterioration of mRS	2 years post procedure

Collaborators and Investigators

• Sponsor: Balt USA
• Investigators: Principal Investigator: Ricardo Hanel, MD. PhD, Baptist Medical Center Jacksonville; Principal Investigator: Vitor M Pereira, MD, MSc, St. Michael's Hospital/Unity Health

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2031

Study Registration Dates

• First Submitted: November 3, 2025
• First Submitted That Met QC Criteria: November 3, 2025
• First Posted (Actual): November 5, 2025

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: 202404 SILK VISTA BABY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes