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Not yet recruiting NCT07561268

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

No phase Interventional Idiopathic Intracranial Hypertension (IIH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SILANCE Stent Implantation.
Who it may be relevant to
Registry conditions: Idiopathic Intracranial Hypertension (IIH). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • Rate of patients with disappearance or significant improvement of IIH related symptoms at first follow-up [Time frame: 6 months]
  • 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]
  • Rate of major adverse events at 6 months (± 3) months and 12 (±3) months [Time frame: 6 months and 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07561268 · SONIC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗