Stenting Of Symptomatic Cerebral siNus stenosIs With the laserCut Self-expanding SILANCE Stent
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcandis GmbH
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- SILANCE Stent Implantation
Treatment groups
99 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov