Operative Procedures vs. Endovascular Neurosurgery for Untreated Pseudotumor Trial
Pseudotumor cerebri, also called idiopathic intracranial hypertension (IIH), is characterized by elevated intracranial pressure, headache, and if severe, vision loss. IIH is difficult to treat. Medical management may not adequately resolve the symptoms, and surgical management (primarily through cerebrospinal fluid \[CSF\] shunting) has a high failure rate. Recently, a relationship between IIH and stenosis of the dural venous sinuses (the veins that drain blood from the brain) has been reported. In patients with IIH in whom there is stenosis of one or more dural venous sinuses, placing a stent in the venous sinus may improve patients' objective symptoms (such as visual loss and papilledema) and subjective symptoms (such as headache). This study will determine whether dural venous sinus stenting is as effective as CSF shunting (considered the standard surgical treatment) in treating IIH patients who have moderate vision loss and stenosis of the dural venous sinuses.
Conditions:
🦠 Pseudotumor Cerebri 🦠 Idiopathic Intracranial Hypertension (IIH)
🗓️ Study Start (Actual) 3 June 2020
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Phoenix, Arizona, United States
📍 Seattle, Washington, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age ≥ 18 years old.
    • * Diagnosis of Idiopathic Intracranial Hypertension according to the Modified Dandy Criteria.
    • * Moderate to severe visual field loss defined by perimetric mean deviation of at least -8 dB but better than -30 dB in the worst eye.
    • * Diagnostic cerebral venography demonstrating a pressure gradient of ≥ 8 mmHg across at least one segment of the dural venous sinus as measured during transfemoral cerebral venography
    • * Failure of conservative or non-surgical therapies,by:
    • 1. failed medical treatment including weight loss regimens OR
    • 2. medication intolerance OR
    • 3. medical treatment not indicated per investigator team
    • * Women must not be able to become pregnant (e.g., post menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study, and have a negative pregnancy test prior to treatment.
    • a. Women on hormonal birth control must be on a stable dose for at least 3 months prior to enrollment
    • * Signed informed consent obtained from the patient.

    Exclusion Criteria:

    • * CSF pressure \<25 cm H2O on lumbar puncture.
    • * Abnormal CSF analysis such as elevated protein (\>60 mg/dL), low glucose (\<30 mg/dL), elevated cell count \>5 (unless traumatic lumbar puncture).
    • * Previous CSF shunt or diversion procedure of any kind, or previous optic nerve sheath fenestration.
    • * Uncontrolled second primary headache disorder (e.g. chronic migraine, medication overuse headache).
    • * Allergic reaction to radiological iodine contrast agent.
    • * Significant renal impairment (serum creatinine \>1.5 mg/dL).
    • * Contraindication to general anesthesia.
    • * Contraindication to aspirin, clopidogrel or other anticoagulants.
    • * Presence of a cranial vascular abnormality (arteriovenous malformation, dural arteriovenous fistula, dural venous sinus thrombosis) or other intracranial mass.
    • * Presence of a hypercoagulable state such as Factor V Leiden, Protein C or S deficiency or anti-cardiolipin syndrome.
    • * Inability to provide reliable and reproducible visual field examinations (\>15% false- positive errors and/or failure to maintain fixation for eye monitoring).
    • * Previous or ongoing eye disease such as glaucoma or retinopathy.
    • * Pre-existing best corrected visual acuity worse than 20/200 in the study eye as measured by Snellen charts, without meeting eligible ophthalmological criteria in the contralateral eye.
    • * Other pre-existing conditions accounting for optic atrophy that could produce irreversible vision loss in the study eye without meeting eligible ophthalmological criteria for IIH in the contralateral eye.
    • * Condition associated with high risk of retinopathy (e.g. type I diabetes).
    • * Previously (within the last 2 months) or currently exposed to a drug or substance that may elevate intracranial pressure (e.g. lithium, high-dose vitamin A, tetracyclines, anabolic steroids, chlordecone, amiodarone, diphenylhydantoin, nalidixic acid).
    • * Pregnancy.
    • * Presence of a physical, mental or social condition that could prevent adequate follow-up such as terminal illness, homelessness, lack of telephone, drug dependency or anticipation of a significant move away from a study site within one year of enrollment.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 July 2015
  • First Submitted that Met QC Criteria 30 July 2015
  • First Posted 3 August 2015

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 May 2024
  • Last Update Posted 31 May 2024
  • Last Verified May 2024