Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBeijing Tiantan Hospital
About this trial
The aim of this study is to assess the efficacy of stent implantation versus medical therapy on idiopathic intracranial hypertension with venous sinus stenosis.
Eligibility criteria
Qualifiers
Subject Eligibility Criteria
Diagnosis of IIH by modified Dandy criteria about for more than 2 months
Lumbar puncture opening pressure ≥250 mmH₂O within 6 weeks before enrollment
Normal cerebrospinal fluid (CSF) composition
Disqualifiers
Subject Exclusion Criteria
Previous surgery for IIH, including optic nerve sheath fenestration (ONSF), CSF shunting, decompressive craniectomy or venous sinus stenting
Progressive or rapid visual loss needed urgent surgical intervention; if delay>24-48 h consider interim lumbar drain (for rapid visual loss only).Surgical options to consider: CSF diversion or optic nerve sheath fenestration
Visual loss due to other etiologies (eg, retinal drusen, retinal and optic neuropathy, cataracts, etc)
Trial design
Treatments tested in this trial
- Stent Implantation
- Acetazolamide-based medical therapy
- Weight loss
Treatment groups
74 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov