RecruitingIntracranial Aneurysm
Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER)
Eligible age
22–80 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Balt USA
You may qualify if…
- ✓ 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 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
- ✓ 6. Participant has pre-procedure (obtained up to 14 days prior to the procedure day) PRU value between 60-200
- ✓ 7. 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
You may not qualify if…
- ✕ 1. Target aneurysm is unsuitable for flow diverter treatment
- ✕ 2. Subject requires more than one flow diverter for target aneurysm treatment
- ✕ 3. 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
- ✕ 4. Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
- ✕ 5. 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
- ✕ 6. Has a known severe allergy to nickel, titanium or platinum
- ✕ 7. Modified Rankin Score (mRS) assessment is ≥ 3 at screening or pre-procedure mRS could not be assessed
- ✕ 8. 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT07225075 · last updated 2026-10-05