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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
SILANCE Stent Implantation
DeviceEndovascular 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.
Treatment groups
99 Participants
are divided into 1 treatment groupGroup A: Implantation of SILANCE Stent / Elimination of the lateral sinus stenosisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months2
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.
Time frame
Periprocedural3
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.
Time frame
6 months and 12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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