Idiopathic Intracranial Hypertension (IIH)SONICNCT07561268
Stenting Of Symptomatic Cerebral siNus stenosIs With the laserCut Self-expanding SILANCE Stent
A study testing SILANCE Stent Implantation in people with Idiopathic Intracranial Hypertension (IIH), run by Acandis GmbH.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Intracranial Hypertension (IIH)
- What is being tested?
- SILANCE Stent Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- SILANCE Stent Implantation
- Keywords
- Symptomatic venous sinus stenosis, IIH, Sinus stenosis, Lateral Sinus Stenosis, Sinus Stenting, Idiopathic intracranial hypertension
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SILANCE Stent ImplantationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Implantation of SILANCE Stent / Elimination of the lateral sinus stenosis | Experimental | Not described Receives: Device: SILANCE Stent Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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).
- 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.
Measured: 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.
Measured: 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.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Intracranial Hypertension (IIH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acandis GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561268
- Sponsor's protocol ID
- SONIC
- Acronym
- SONIC
- Status last verified
- Apr 2026
- First submitted
- 27 Aug 2025
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: European manufacturer sponsored study
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stenting Of Symptomatic Cerebral siNus stenosIs With the laserCut Self-expanding SILANCE Stent
- ClinicalTrials.gov ID
- NCT07561268
- Acronym / sponsor ID
- SONIC / SONIC
- Keywords
- Symptomatic venous sinus stenosis, IIH, Sinus stenosis, Lateral Sinus Stenosis, Sinus Stenting, Idiopathic intracranial hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Acandis GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation of SILANCE Stent / Elimination of the lateral sinus stenosis | Experimental | Device: SILANCE Stent Implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SILANCE Stent ImplantationEndovascular 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. | Device | Implantation of SILANCE Stent / Elimination of the lateral sinus stenosis |
Primary outcome
Rate of patients with disappearance or significant improvement of IIH related symptoms at first follow-up
Time frame: 6 months
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.
Time frame: Periprocedural
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
Time frame: 6 months and 12 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No. European manufacturer sponsored study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing SILANCE Stent Implantation in people with Idiopathic Intracranial Hypertension (IIH), run by Acandis GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Gold (+49 7231 155000, info@acandis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with disappearance or significant improvement of IIH related symptoms at first follow-up (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.