Operative Procedures Vs. Endovascular Neurosurgery for Untreated Pseudotumor Trial

NCT02513914 | Suspended FDA Device

• 1 other identifier: 15BN045
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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)

Keywords

endovascular neurosurgery

Outcome Measures

Primary Outcomes (1)

• Perimetric mean deviation (PMD) at six months

  PMD was chosen as a primary outcome due to its generalizability, test-retest reliability and standardization across centers, as well as its sensitivity to severity and progression of visual symptoms of IIH. Based on previous work by the Neuro-Ophthalmology Research Disease Investigator Consortium (NORDIC) investigators, we defined the upper and lower bounds of visual field loss severity for study inclusion as between -8 and -30 dB in the worst-affected eye. The upper limit of -8 dB ensures enough baseline visual loss to consider surgical treatment and allow room for improvement, while the lower limit of -30 dB ensures that patients with severe visual loss unlikely to significantly improve with any treatment would be excluded. PMD will be tested using Swedish Interactive Threshold Algorithm (SITA) standard 24-2 perimetry with stimulus size III.

  Six months

Secondary Outcomes (4)

• Total number of IIH-related surgeries at one year

  Six months and One year

• Papilledema

  Study entry, two-weeks post-operative and six months

• Quality of life

  Study entry, six months and One year

• Medication usage

  Two-weeks post-operative, six months and One year

Study Arms (2)

Dural Venous Sinus Stenting

EXPERIMENTAL

Pt. will undergo pre-treatment with aspirin and clopidogrel. Transfemoral venous access will be obtained (pt. heparinized).Guide catheter will be placed in jugular bulb ipsilateral to dural venous sinus stenosis. Stent will be deployed across stenotic segment. Balloon angioplasty will not be performed unless initial stenosis is not easily traversed with stent. No pressure measurements will be taken during stent placement. Patients will undergo serial physical/neuro exams for 24 hours post-procedure. Daily dual anti-platelet treatment will continue for 6 months after initial procedure, after which clopidogrel will be discontinued and aspirin 81mg daily will be prescribed indefinitely. If significant bilateral venous sinus stenosis is present, stenosis with more severe pressure gradient will be stented. In pt. with bilateral venous sinus stenosis with equivalent pressure gradients, side will be at surgeon's discretion.

Device: Dural Venous Sinus Stenting

Cerebrospinal Fluid Shunting

ACTIVE COMPARATOR

Choice of shunt procedure (ventriculoperitoneal, ventriculoatrial, or lumboperitoneal), catheter laterality, brand and shunt equipment (including shunt catheters and valves), valve settings of programmable shunt valves (when applicable), intrathecal antibiotic administration and the use of stereotactic navigation will be at the discretion of neurosurgeon. Shunt procedures will be performed per the standard of care, under general anesthesia. An optional surgical procedure guidance document will be provided for other sites. Patients will undergo serial physical and neurological examinations for 24 hours post-procedure prior to discharge.

Device: Cerebrospinal Fluid Shunting

Interventions

Dural Venous Sinus Stenting DEVICE

See Dural Venous Sinus Stenting arm.

Dural Venous Sinus Stenting

Cerebrospinal Fluid Shunting DEVICE

See Cerebrospinal Fluid Shunting arm.

Cerebrospinal Fluid Shunting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• failed medical treatment including weight loss regimens OR
• medication intolerance OR
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• Barrow Neurological Institute: collaborator

Study Sites (2)

Barrow Neurological Institute at Dignity Health St. Joseph's Hospital &amp; Medical Center

Phoenix, Arizona, 85013, United States

Location

University of Washington Department of Neurosurgery

Seattle, Washington, 98103, United States

Location

MeSH Terms

Conditions

Pseudotumor Cerebri

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Felipe C Albuquerque, MD

  Barrow Neurosurgical Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 3, 2015
• Study Start: June 3, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)