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

Eksperimentell: Implantation of SILANCE Stent / Elimination of the lateral sinus stenosis

Enhet: SILANCE Stent Implantation

Endovascular treatment of the lateral sinus stenosis is performed using the SILANCE stent with the aim of eliminating the stenosis and achieving resolution of the associated clinical symptoms.

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

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.

2. 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).

3. 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.

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

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.

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