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.
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