Stenting Of Symptomatic Cerebral siNus stenosIs With the laserCut Self-expanding SILANCE Stent (NCT07561268) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Stenting Of Symptomatic Cerebral siNus stenosIs With the laserCut Self-expanding SILANCE Stent
99 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of patients with disappearance or significant improvement of IIH related symptoms at first follow-up
Timeframe: 6 months
2
Number of patients with disappearance or a clinically significant reduction of the transstenotic venous pressure gradient following implantation of the SILENCE stent.
Timeframe: Periprocedural
3
Rate of major adverse events at 6 months (± 3) months and 12 (±3) months