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Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT05707442•Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

The aim of this study is to assess the efficacy of stent implantation versus medical therapy on idiopathic intracranial hypertension with venous sinus stenosis.

Detailed Description

The SIMPLE is a multicentered, prospective, randomized, open-label, blinded end-point clinical trial. A total of 74 patients with idiopathic intracranial hypertension (IIH) and venous sinus stenosis (VSS) for more than 2 months will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups (stenting or medical therapy) after offering informed content.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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 brain parenchyma without hydrocephalus, mass, or any structural lesion and no evidence of meningeal enhancement on CT or MRI
•5. Localized venous sinus stenosis (VSS) with stenotic degree ≥ 50% on DSA, and pressure gradient across stenosis ≥ 8 mmHg
•6. Patients or their relatives signed written informed consent
•Ophthalmic Eligibility Criteria:
•1. At least one eye had the presence of papilledema
•2. At least one eye of visual field loss: PMD ranging from - 2dB and below; decreased visual function on automated perimetry was reproducible with a false-positive rate of no more than 15%
+1 more criteria

Exclusion Criteria

•1. Previous surgery for IIH, including optic nerve sheath fenestration (ONSF), CSF shunting, decompressive craniectomy or venous sinus stenting
•2. 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
•3. Visual loss due to other etiologies (eg, retinal drusen, retinal and optic neuropathy, cataracts, etc)
•4. Other condition requiring the use of diuretics, steroids or other drugs to reduce intracranial pressure
•5. DSA showed diffused venous sinus stenosis, cortical or deep vein stenosis
•6. A history of severe thyroid disease and iodine allergy
•7. Pregnant or lactating women
•8. Severe cardiopulmonary, liver or kidney failure
•9. Known hereditary or acquired haemorrhagic diathesis
•10. Known hereditary or acquired thrombophilia
+10 more criteria

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

February 16, 2023

Primary Completion Date

January 1, 2027

Completion Date

March 1, 2027

Last Updated

February 10, 2026

Enrollment

ESTIMATED participants

Conditions

Idiopathic Intracranial HypotensionVenous Sinus Stenosis

Interventions

Stent Implantation

PROCEDURE

Acetazolamide-based medical therapy

DRUG

Weight loss

BEHAVIORAL

Contacts

Xu Tong, MD

CONTACT

+8617611338800 dongri0514@sina.com