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Recruiting
NCT07225075
Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER)
Conditions: Intracranial Aneurysm
Sex: All
Ages: 22 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 250
Sponsor: Balt USA
Location: Vascular and Neuroscience Institute of Southern California Thousand Oaks California
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT07225075). StuddyBuddy aggregates publicly available trial information.
