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

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

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.

Inclusion Criteria:

• Diagnosis of idiopathic intracranial hypertension (IIH) according to the Modified Dandy Criteria.
• Cerebrospinal fluid (CSF) lumbar puncture opening pressure > 25 cm H₂O.
• Presence of lateral venous sinus stenosis confirmed by venous magnetic resonance angiography (MRA) or venous computed tomography angiography (CTA).
• Presence of clinical symptoms consistent with IIH, including headaches, visual field loss, papilledema or pulsatile tinnitus.
• Venous pressure gradient across the stenosis > 3 mmHg under general anaesthesia, > 4 mmHg under local anaesthesia.
• Temporal Bone CT done for Patients suffering from Pulsatile Tinnitus
• Written informed consent obtained prior to any study-related procedures.