Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)

Recruiting Phase 3 Interventional Study
Idiopathic Intracranial Hypotension Venous Sinus Stenosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
74 (estimated)
Sponsor
Beijing Tiantan Hospital · Other
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Subject Eligibility Criteria 1. Diagnosis of IIH by modified Dandy criteria about for more than 2 months 2. Lumbar puncture opening pressure ≥250 mmH₂O within 6 weeks before enrollment 3. Normal cerebrospinal fluid (CSF) composition 4. Neuroimaging showing normal brai…
Contacts

Xu Tong, MD

+8617611338800

dongri0514@sina.com

CONTACT