Clinical trial NCT05707442: Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)
Official title: Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Idiopathic Intracranial Hypotension
Venous Sinus Stenosis
Keywords: Idiopathic intracranial hypertension
Venous sinus stenosis
Stenting
Medical therapy
Randomized controlled trial
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* Subject Eligibility Criteria

  1. Diagnosis of IIH by modified Dandy criteria 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. Visual loss due to other etiologies (eg, retinal drusen, retinal and optic neuropathy, cataracts, etc)
  3. Other condition requiring the use of diuretics, steroids or other drugs to reduce intracranial pressure
  4. DSA showed diffused venous sinus stenosis, cortical or deep vein stenosis
  5. A history of severe thyroid disease and iodine allergy
  6. Pregnant or lactating women
  7. Severe cardiopulmonary, liver or kidney failure
  8. Known hereditary or acquired haemorrhagic diathesis
  9. Known hereditary or acquired thrombophilia
  10. Platelet counts or coagulation abnormality
  11. Major surgery or severe trauma or any traumatic brain injury within the previous 14 days
  12. A history of cerebral hemorrhage, arteriovenous malformation, intracranial aneurysm or tumor
  13. 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
  14. 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)

Primary outcomes:
measure: Perimetric Mean Deviation (PMD)
timeFrame: 6 months
Secondary outcomes:
measure: Cerebrospinal Fluid (CSF) Opening Pressure
timeFrame: 6 months
measure: Papilledema Grade: Frisén grade(0-5 scores,and higher scores mean worse outcome)
timeFrame: 6 months
measure: Retinal Nerve Fiber Layer Thickness
timeFrame: 6 months
measure: Total Retinal Thickness
timeFrame: 6 months
measure: Visual Acuity: National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25, minimum and maximum values: 0-100 points, higher scores mean a better visual function)
timeFrame: 6 months
measure: Visual Acuity: 10-item neuro-ophthalmic supplement to the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) (minimum and maximum values: 0-100 points, higher scores mean a better visual function)
timeFrame: 6 months
measure: Headache: Headache Impact Test-6 (HIT-6, minimum and maximum values: 36-78 points, higher scores mean greater headache severity)
timeFrame: 6 months
measure: Pulsatile tinnitus: Tinnitus Handicap Inventory (THI, minimum and maximum values: 0-100 points, higher scores mean more serious tinnitus disability)
timeFrame: 6 months
Other outcomes:
measure: Functional health status and quality of life:EuroQol five dimensions questionnaire (EQ-5D,0-100,higher scores mean a better outcome)
timeFrame: 6 months
measure: Cost-effectiveness analysis (mean costs per patient)
timeFrame: 6 months
measure: Cost-effectiveness analysis (quality-adjusted life years)
timeFrame: 6 months
measure: Cost-effectiveness analysis (the cost saving per extra patient with a good outcome)
timeFrame: 6 months
measure: Cost-effectiveness analysis (the cost saving per additional quality-adjusted life year)
timeFrame: 6 months
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Dapeng Mo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Zhongrong Miao, MD
role: PRINCIPAL_INVESTIGATOR
References: