Stenting Of Symptomatic Cerebral siNus stenosIs With the laserCut Self-expanding SILANCE Stent
Starting soon · Not applicable
Conditions studied: Idiopathic Intracranial Hypertension (IIH)
In brief
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.
Key facts
- Study ID
- NCT07561268
- Run by
- Acandis GmbH
- People needed
- 99
- Starts
- 2026-09-01
- Expected to finish
- 2029-10-01
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Full record on ClinicalTrials.gov
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