Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER)
Balt USA
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.
Eligibility
- Age range
- 22–80 years
- Sex
- All
- Healthy volunteers
- No
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 ances…
Interventions
- DeviceSilk 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.
Locations (3)
- Vascular and Neuroscience Institute of Southern CaliforniaThousand Oaks, California
- Baptist HealthJacksonville, Florida
- St. Michael's Hospital/Unity HealthToronto, Ontario