Comparing stent implantation to medical therapy for idiopathic intracranial hypertension

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

This study is testing whether putting in a stent helps people with idiopathic intracranial hypertension feel better compared to just using medication.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05707442 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of stent implantation compared to medical therapy in patients with idiopathic intracranial hypertension (IIH) and venous sinus stenosis (VSS). It is a multicentered, prospective, randomized, open-label trial that will enroll 74 patients diagnosed with IIH for more than two months. Participants will be randomly assigned to receive either stenting or acetazolamide-based medical therapy, with the primary goal of assessing treatment outcomes. The study will also monitor changes in visual function and intracranial pressure.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with idiopathic intracranial hypertension and venous sinus stenosis who meet specific inclusion criteria.

Not a fit: Patients with conditions that do not meet the eligibility criteria or those who have previously undergone treatment for IIH may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from idiopathic intracranial hypertension.

How similar studies have performed: Other studies have explored similar interventions, but this specific comparison of stenting versus medical therapy in IIH is relatively novel.

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 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%
  3. Visual acuity above 20 / 200 (≥ 39 letters)

Exclusion Criteria:

* Subject 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
  11. Platelet counts or coagulation abnormality
  12. Major surgery or severe trauma or any traumatic brain injury within the previous 14 days
  13. A history of cerebral hemorrhage, arteriovenous malformation, intracranial aneurysm or tumor
  14. Other life threatening illness (eg, advanced cancer) likely to lead to death within a few months; the physical, psychological and social status of patients may affect follow-up (eg, drug addiction, advanced malignant disease, no telephone, no family, etc); cannot tolerate general anesthesia
  15. Increased intracranial pressure due to other secondary factors
* Ophthalmic Exclusion Criteria:

  1. Current intraocular pressure \> 28mmHg or previous intraocular pressure \> 30mmHg
  2. Refractive error spherical power greater than -6.0D or +6.0D and astigmatism greater than 3.0D, except for the following cases:

     1. Myopia of - 6.0D to - 8.0D with the following: 1)There was no myopia related disease that can lead to decreased vision under the eyeground microscope (eg, scleral staphyloma, retinal thinning at the posterior pole, and moderate to severe disc tilt); 2) The patient wore contact lenses of appropriate degree for all visual field examinations.
     2. Hyperopia of +6.0D to +8.0D with the following: 1) The presence of a well characterized peri optic disc edematous halo, as opposed to crowded small optic discs or other features of decreased visual acuity associated with hyperopic changes, was at the discretion of the site investigator or reading center leader (or his designee); 2) The patient wore contact lenses of appropriate degree for all visual field examinations.
  3. Examination visible or past medical history known to have large optic disc drusen (persistent optic disc edema can present with small optic disc drusen, as low numbers are acceptable for inclusion and to be determined by the investigator to be unrelated to vision loss)

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Dapeng Mo, MD — Beijing Tiantan Hospital
• Study coordinator: Xu Tong, MD

Conditions Idiopathic Intracranial Hypotension; Venous Sinus Stenosis; Idiopathic intracranial hypertension; Venous sinus stenosis; Stenting; Medical therapy; Randomized controlled trial