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.
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
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
Single group
Silk Vista Baby (SVB) Flow Diverter
DeviceThe 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.
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
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
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
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
Unplanned alternative treatment of the target IA
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
Occurrence of all SVB device and/or procedure related AEs
Proportion of participants with no change, improvement, or deterioration of mRS
