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Intracranial AneurysmPIONEERNCT07225075

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

A study testing Silk Vista Baby (SVB) Flow Diverter in people with Intracranial Aneurysm, run by Balt USA at 6 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 22 to 80 years
Conditions the study is for
Intracranial Aneurysm
What is being tested?
Silk Vista Baby (SVB) Flow Diverter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
6 sitesin 2 countries
Study dates
4 Feb 2026to Feb 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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
  • 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)
  • Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)
  • Unable to complete study follow-up due to dementia or psychiatric disorder, substance abuse, or history of noncompliance with medical advice
  • Women who are pregnant or nursing at the time of enrollment or women who wish to become pregnant during the length of study participation
  • 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
  • Participation in any other investigational study which can influence collection of valid data under this study

Trial locations and contacts

6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Gregory Tirrell contact

949-788-1443

gregory.tirrell@baltgroup.com

Richelle Massey contact

richelle.massey@baltgroup.com

6 sites in 2 countries

United States5 sites, 5 recruiting

  • University of Buffalo Neurosurgery

    Buffalo, New York, 14221

    Ellen Carl

    Recruiting

  • Baptist Health

    Jacksonville, Florida, 32207

    Teresa Nicol

    Recruiting

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

    Jay Gutta

    Recruiting

  • Vascular and Neuroscience Institute of Southern California

    Thousand Oaks, California, 91360

    Priya Kaushal

    Recruiting

  • John Muir Health - Walnut Creek Hospital

    Walnut Creek, California, 94598

    Melanie Aaron

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • St. Michael's Hospital/Unity Health

    Toronto, Ontario, M5C 1R6

    Eileen Liu

    Recruiting

Other trials in Canada

About this study

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.

Being tested
Silk Vista Baby (SVB) Flow Diverter
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Silk Vista Baby (SVB) Flow DiverterDevice

    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 groups in NCT07225075
Study groupRoleWhat they receive
Silk Vista Baby (SVB) Flow DiverterExperimentalParticipants meeting eligibility criteria will undergo endovascular treatment of a single unruptured intracranial aneurysm using the SVB Flow Diverter.
Receives: Device: Silk Vista Baby (SVB) Flow Diverter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year post procedure

Secondary outcomes (9)

  1. 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

    Measured: 180 days and 2 years post-procedure

  2. 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

    Measured: 180 days, 1 year, and 2 years post-procedure

  3. 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

    Measured: Within 180 days, 1 year, and 2 years post procedure

  4. Unplanned alternative treatment of the target IA

    Measured: Within 1 year post procedure

  5. Device deployment success rate

    Measured: Index procedure

  6. Device migration rate

    Measured: 180 days, 1 year, and 2 years post procedure

  7. Evolution of occlusion between post-procedure and timepoints listed under timeframe, as adjudicated by an independent Core Lab

    Measured: 1 year and 2 years post procedure

  8. Occurrence of parent artery occlusion

    Measured: 1 year and 2 years post procedure

  9. Occurrence of >50% In-Stent Stenosis at the target IA

    Measured: 1 year and 2 years post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2025
  2. Study start4 Feb 2026
  3. Primary completionFeb 2030 (estimated)
  4. Study completionFeb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07225075
Sponsor's protocol ID
202404 SILK VISTA BABY
Acronym
PIONEER
Status last verified
Oct 2026
First submitted
3 Nov 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Silk Vista Baby (SVB) Flow Diverter in people with Intracranial Aneurysm, run by Balt USA at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gregory Tirrell (949-788-1443, gregory.tirrell@baltgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07225075.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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