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Search / Trial NCT05707442

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

Launched by BEIJING TIANTAN HOSPITAL · Jan 28, 2023

Trial Information

Current as of August 23, 2025

Recruiting

Keywords

Idiopathic Intracranial Hypertension Venous Sinus Stenosis Stenting Medical Therapy Randomized Controlled Trial

ClinConnect Summary

The SIMPLE trial is studying how well a stent, a small tube placed in blood vessels, works compared to medication for treating idiopathic intracranial hypertension (IIH) caused by a narrowing in the veins in the brain. This condition can lead to increased pressure inside the skull, which may cause headaches and vision problems. The trial is looking for participants aged 6 to 74 who have been diagnosed with IIH for at least two months and have specific symptoms, such as increased pressure in their spinal fluid and signs of vision loss.

If you or a family member are considering joining this trial, you should know that participants will undergo tests to confirm their condition and ensure they meet the eligibility criteria. Those who qualify will have the chance to receive either the stent procedure or standard medical treatment. The trial is currently recruiting, and participants will have their health monitored closely throughout the study. This research could help determine the best treatment options for IIH, potentially improving outcomes for many patients in the future.

Gender

ALL

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)

About Beijing Tiantan Hospital

Beijing Tiantan Hospital, affiliated with Capital Medical University, is a leading medical institution in China renowned for its expertise in neurology, neurosurgery, and various other specialties. As a prominent clinical trial sponsor, the hospital is committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on high-quality clinical trials, Beijing Tiantan Hospital adheres to rigorous ethical standards and regulatory requirements, fostering collaboration with academic institutions and industry partners to facilitate the development of cutting-edge therapies and interventions. Its state-of-the-art facilities and experienced research team enable the hospital to play a pivotal role in the global medical research landscape.

Locations

Beijing, Beijing, China

Patients applied

0 patients applied

Trial Officials

Dapeng Mo, MD

Principal Investigator

Beijing Tiantan Hospital

Zhongrong Miao, MD

Principal Investigator

Beijing Tiantan Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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