The objective of this clinical investigation is to evaluate and demonstrate the clinical benefit, performance, and safety of the SILANCE Stent, which is specifically designed for the treatment of patients with symptomatic sinus stenoses associated with IIH.
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Rate of patients with disappearance or significant improvement of IIH related symptoms at first follow-up
Timeframe: 6 months
Number of patients with disappearance or a clinically significant reduction of the transstenotic venous pressure gradient following implantation of the SILENCE stent.
Timeframe: Periprocedural
Rate of major adverse events at 6 months (± 3) months and 12 (±3) months
Timeframe: 6 months and 12 months