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

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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]

Secondary outcome measures (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 [Time frame: 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 [Time frame: 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 [Time frame: Within 180 days, 1 year, and 2 years post procedure]
• Unplanned alternative treatment of the target IA [Time frame: Within 1 year post procedure]
• Device deployment success rate [Time frame: Index procedure]
• Device migration rate [Time frame: 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 [Time frame: 1 year and 2 years post procedure]
• Occurrence of parent artery occlusion [Time frame: 1 year and 2 years post procedure]
• Occurrence of >50% In-Stent Stenosis at the target IA [Time frame: 1 year and 2 years post procedure]

Eligibility criteria

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
• 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

Exclusion criteria

• 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Vascular and Neuroscience Institute of Southern California — Thousand Oaks
• Baptist Health — Jacksonville

Canada · 1 center

• St. Michael's Hospital/Unity Health — Toronto

Identifiers

NCT: NCT07225075 · 202404 SILK VISTA BABY

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗