Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER)
NCT07225075 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2026-07-17
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
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.
Sponsors & Collaborators
-
Balt USA
lead INDUSTRY
Principal Investigators
-
Ricardo Hanel, MD. PhD · Baptist Medical Center Jacksonville
-
Vitor M Pereira, MD, MSc · St. Michael's Hospital/Unity Health
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-04
- Primary Completion
- 2030-02-28
- Completion
- 2031-02-28
- FDA Device
- Yes
Countries
- United States
- Canada
Study Locations
More Related Trials
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT00727805 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02280577 ·Status: WITHHELD
-
Home-based Under Mattress Monitor for OSA
NCT07186725 ·Status: RECRUITING ·Phase: NA
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07282535 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07215377 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT05050175 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT01627405 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06854055 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT05226975 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT05083507 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT05220176 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT04680507 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02108275 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT01790867 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02800057 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT05450250 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07222124 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02218450 ·Status: WITHHELD
-
Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
NCT07211035 ·Status: RECRUITING ·Phase: NA
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT01556750 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07222319 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07223788 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07226024 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07227129 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT01180257 ·Status: WITHHELD