Investigator-initiated clinical trial of stabilizer device: A novel intracranial exchange guidewire for neuroendovascular treatments.
Chiaki Sakai, Nobuyuki Sakai, Catherine Peterson et al.
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In 30 seconds
This single-arm, prospective, open-label, multicenter clinical trial evaluated the Stabilizer intracranial exchange guidewire in 31 patients treated for intracranial aneurysms or artery stenosis at nine Japanese centers. The device was used to exchange for several neuroendovascular devices, including catheters, PTA balloons, and a Wingspan stent system. Technical success was 100%. Three treatment-related complications occurred, but none was attributed to the Stabilizer device, and no device-related vascular damage was reported.
Key findings
- Technical success with the Stabilizer device was 100% among 31 enrolled patients.
- Three treatment-related complications were reported; none was considered device-related.
- No device-related vascular damage was reported.
Why it matters
Exchange maneuvers can be needed to reach difficult neurovascular lesions, yet may risk vessel injury. This trial provides early multicenter clinical evidence that the Stabilizer could facilitate device exchange with high technical success and no reported device-related complications. These findings are relevant to assessing an alternative exchange tool, while the study design and size limit certainty about safety and effectiveness.
What to keep in mind
The study was single-arm and included 31 patients, so it provides no comparator and limited evidence for estimating uncommon complications or comparative effectiveness.