🏛️ Verified NIH Record • Updated 2026-07-15
Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER) (NCT07225075)
🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Balt USA
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Vascular and Neuroscience Institute of Southern California — Thousand Oaks, California
Age range: 22 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (3 Sites)
- Vascular and Neuroscience Institute of Southern California — Thousand Oaks, California
- Baptist Health — Jacksonville, Florida
- St. Michael's Hospital/Unity Health — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (949) 788-1443
Email: gregory.tirrell@baltgroup.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study — Hollywood, Florida
- Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation — Jacksonville, Florida
- Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial — Sherbrooke, Quebec
- NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study — Jacksonville, Florida
Explore by condition: All Intracranial Aneurysm clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.