Stenting Of Symptomatic Cerebral siNus stenosIs With the laserCut Self-expanding SILANCE Stent

Primary outcomes

1. Rate of patients with disappearance or significant improvement of IIH related symptoms at first follow-up

   Time frame: 6 months

   The disappearance or significant improvement of symptoms related to venous sinus stenosis at the first follow-up (6 months) will be evaluated as follows:

   1 Headaches will be assessed using the Headache Impact Test (HIT-6). The scale consists of six items with five-point response options and yields a total score ranging from 36 to 78, with higher scores indicating greater headache-related impairment.

   • Pulsatile tinnitus will be assessed using the Tinnitus Functional Index (TFI). The Tinnitus Functional Index (TFI) is a validated 25-item patient-reported measure of tinnitus severity across eight domains, yielding a total score from 0 to 100 (higher scores indicating greater severity).

   • Visual impairment will be assessed using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25).It consists of 25 items across multiple subscales and provides subscale as well as an overall score ranging from 0 to 100, where higher scores indicate better vision-related quality.

2. Number of patients with disappearance or a clinically significant reduction of the transstenotic venous pressure gradient following implantation of the SILENCE stent.

   Time frame: Periprocedural

   Venous pressure is measured at at least two locations: proximal (upstream) to the stenosis at the torcular Herophili and distal (downstream) to the stenosis at the jugular bulb. Only patients demonstrating a venous pressure gradient of > 3 mmHg under general anesthesia and > 4 mmHg under local anesthesia are eligible for inclusion in the study. The pressure gradient is assessed both before and after stent implantation. A reduction in the pressure gradient is considered indicative of achieving the efficacy endpoint.

3. Rate of major adverse events at 6 months (± 3) months and 12 (±3) months

   Time frame: 6 months and 12 months

   MAEs are defined as symptomatic, serious, procedure- or device-related post-procedure complications: major stroke, neurological death, in-stent thrombosis, target vessel restenosis, stent-adjacent stenosis, or stent migration.