NCT07561268Not yet recruiting
Stenting Of Symptomatic Cerebral siNus stenosIs With the laserCut Self-expanding SILANCE Stent
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 99 (estimated)
- First submitted
- 27 Aug 2025
- Start date
- Sept 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- Acandis GmbH
- Diseases
- High blood pressure
- NCT number
- NCT07561268
What you commit to
- Study type: Interventional
- Planned participants: 99
- From Sept 2026 to the primary completion date, Oct 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.