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

NCT07225075 | Recruiting DMC FDA Device

• 1 other identifier: 202404 SILK VISTA BABY
• Study Type: interventional
• Target: 250
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Other Outcomes (3)

• 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

Study Arms (1)

Silk Vista Baby (SVB) Flow Diverter

EXPERIMENTAL

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

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.

Silk Vista Baby (SVB) Flow Diverter

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Participant has a target IA that is ≤ 12 mm
• 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
• Participant has pre-procedure (obtained up to 14 days prior to the procedure day) PRU value between 60-200
• 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

You may not qualify if:

• Target aneurysm is unsuitable for flow diverter treatment
• Subject requires more than one flow diverter for target aneurysm 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
• Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
• 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
• Has a known severe allergy to nickel, titanium or platinum
• Modified Rankin Score (mRS) assessment is ≥ 3 at screening or pre-procedure mRS could not be assessed
• 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
• Subarachnoid hemorrhage occurred within 30 days prior to enrollment
• Intracranial parenchymal hemorrhage occurred within 60 days prior to enrollment
• Major surgery (including previous intracranial implant) occurred within previous 30 days or is planned in the next 120 days after treatment date
• Has more than one IA that requires treatment within 120 days of treatment date
• Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 12 weeks prior to treatment date
• Requires adjunctive coiling during SVB procedure
• Chronic anticoagulation therapy is ongoing or known coagulopathy exists

Sponsors & Collaborators

• Balt USA: lead

Study Sites (3)

Vascular and Neuroscience Institute of Southern California

Thousand Oaks, California, 91360, United States

RECRUITING

Baptist Health

Jacksonville, Florida, 32207, United States

RECRUITING

St. Michael's Hospital/Unity Health

Toronto, Ontario, M5C 1R6, Canada

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ricardo Hanel, MD. PhD

  Baptist Medical Center Jacksonville

  PRINCIPAL INVESTIGATOR

• Vitor M Pereira, MD, MSc

  St. Michael's Hospital/Unity Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory Tirrell

CONTACT

949-788-1443; gregory.tirrell@baltgroup.com

Richelle Massey

CONTACT

richelle.massey@baltgroup.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 5, 2025
• Study Start: February 4, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2031
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)