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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Intracranial Hypertension (IIH)
• Intervention / Treatment: Device: SILANCE Stent Implantation

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Gold; Phone Number: +49 7231 155000; Email: info@acandis.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implantation of SILANCE Stent / Elimination of the lateral sinus stenosis	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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.	Periprocedural
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.	6 months and 12 months

Collaborators and Investigators

• Sponsor: Acandis GmbH

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: August 27, 2025
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: IIH; Idiopathic intracranial hypertension; Symptomatic venous sinus stenosis; Sinus stenosis; Lateral Sinus Stenosis; Sinus Stenting
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension; Pseudotumor Cerebri
• Other Study ID Numbers: SONIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: European manufacturer sponsored study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No