Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT02513914 |
Other study ID # |
15BN045 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 3, 2020 |
Est. completion date |
December 2025 |
Study information
Verified date |
May 2024 |
Source |
St. Joseph's Hospital and Medical Center, Phoenix |
Contact |
Praveena Mohan |
Phone |
602-406-3032 |
Email |
Praveena.Mohan[@]dignityhealth.org |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Screening evaluation: Screening will include standard-of-care IIH evaluation including
general medical and neurological examinations, blood chemistries, complete blood count,
prothrombin time (PT),partial thromboplastin time (PTT), and pregnancy test. Ophthalmological
evaluation will include visual acuity, pellucid marginal degeneration (PMD), and optical
coherence tomography (OCT). Quality of life assessments are Headache Impact Test-6, Short
Form Health Survey-36 and Visual Function Questionnaire-25 + Neuro-Ophthalmology supplement
tests. Participants must have had a recent (within 6 months of enrollment) magnetic resonance
imaging (MRI) of the brain as well as a diagnostic lumbar puncture (including opening
pressure, cerebrospinal fluid (CSF) cell count, CSF glucose and CSF protein), both of which
are also part of the standard of care for diagnosis of IIH.
Eligible patients will undergo outpatient diagnostic venography within one month of initial
IIH evaluation. Under local anesthesia, transfemoral venous access will be obtained and a
guide catheter will be placed in the right jugular bulb. A microcatheter (Excelsior SL-10,
Stryker Neurovascular) will then be advanced into the dural venous sinuses, and venography
will be performed to determine the presence of any dural venous sinus stenosis. Then, blood
pressure will be transduced through the microcatheter at the following anatomic locations:
Anterior superior sagittal sinus, posterior superior sagittal sinus, bilateral transverse
sinuses, bilateral sigmoid sinuses and bilateral jugular bulbs. The venous pressure gradient
will be defined as the difference in pressure measurements between the anatomic locations
proximal and distal to any stenotic venous sinus segment, or between the transverse and
sigmoid sinuses. A pressure gradient of ≥ 8 mmHg is considered sufficient for subsequent
randomization. In patients in which pressure gradient is < 8 mmHg, the patient will not be
randomized.
Subsequent visits: Once a patient has met eligibility criteria and undergone randomization,
treatment will occur within one month of the Neuro-Ophthalmology evaluations and within one
month of diagnostic venography. Follow-up visits will occur at post procedure prior to
discharge (24 hours), two weeks, six months and one year after the index procedure.
At post-procedure follow-up, patients will undergo physical and neurological exams. At
two-week follow-up (within one week on either side), patients will undergo neurological and
ophthalmological evaluations, OCT, perimetry, and visual acuity testing for safety. While
perimetry at this point will not be used for primary outcome analysis, substantial worsening
in any of the above measures despite treatment will prompt consideration for treatment
failure.
At six-month follow-up, subjects will undergo perimetry for primary outcome analysis,
outpatient diagnostic cerebral venography, and pressure measurements identical to that of the
screening evaluation (including pressure measurements at all predefined anatomical locations)
within four weeks on either side of the six-month target date. At both six-month and one-year
follow-up visits, patients will complete follow-up quality of life questionnaires (HIT-6,
SF-36 and VFQ-25 + Neuro-Ophthalmology supplement).These visits will also include queries
regarding interim medical history, headache status, medication usage (specifically details
and dose of those agents used to treat IIH or headache), and the number of IIH-related
procedures each subject has undergone since the index procedure. At one-year follow-up, the
patient will undergo Magnetic Resonance Venography (MRV) or Computed Tomography Venography
(CRV) to assess patency of stented dural sinus. Follow-up will occur within four weeks on
either side of the one-year target date.