The objective of the study is to show that stenting the transverse-sigmoid sinus with the River stent is safe and has probable benefit to relieve clinical symptoms in subjects with idiopathic intracranial hypertension (IIH). The study will enroll 39 IIH subjects with moderate to severe visual field loss or severe headaches that have failed medical therapy. The primary safety endpoint is the rate of major adverse event at 12 months The primary probable benefit endpoint is a composite at 12 months of absence of significant sinus stenosis and clinically relevant improvement.
Study objective: The objective of the study is to show that stenting the transverse-sigmoid sinus with the River stent is safe and has probable benefit to relieve clinical symptoms in subjects with idiopathic intracranial hypertension (IIH) Investigational product: Serenity River Stent System Study design: prospective, multicenter, single arm, open label clinical trial Subject population: IIH subjects with significant (\>50%) stenosis of the transverse-sigmoid sinuses and moderate to severe visual field loss or severe headaches that have failed medical therapy. In the absence of this trial, subjects would have been offered a surgical treatment of IIH such as sinus stenting with an off-label device, cerebrospinal fluid shunting, or optic nerve sheath fenestration by the treating physician. * For subjects with visual field loss: if moderate to severe visual field loss (mean deviation between -6db and -30 db) for at least 2 weeks despite escalation of acetazolamide to 1000 mg twice a day or if the visual field deteriorates by more than 2 db during treatment, or treatment intolerance. * For subjects with headaches: if they have severe headaches (HIT \> 59) for at least 4 weeks despite treatment with topiramate 100 mg twice a day or other headache medication, or treatment intolerance. Enrollment size and sites: 39 subjects will be enrolled in up to 10 US sites. Primary safety endpoint: Major Adverse Event at 12 months. The MAE is a composite of the following: moderate or severe stroke (NIHSS \> 3), neurological death, perforation or thrombosis of sinus or cerebral vein, device distal embolization, need for target lesion revascularization or need for alternate IIH surgical procedure such as cerebrospinal fluid shunting or optic nerve sheath fenestration. Primary probable benefit endpoint: a composite at 12 months of: * Absence of significant (\>50%) stenosis of the stented sinus on retrograde catheter venography and * Trans-stent pressure gradient \< 8 mm Hg and * Clinically relevant improvement in the main clinical outcome per specific inclusion criteria and stabilization or better of the other: * Headaches: if the specific inclusion criteria was headaches, improvement in the HIT- 6 scale by \> 4 points and improvement or stabilization of visual field. * Ophthalmic: if the specific inclusion criteria was visual field loss, improvement of visual field by \> 29% of the baseline value in the study eye, stabilization or improvement in the fellow eye, and improvement or stabilization of headaches. Study duration and follow-up: The subjects will be followed at 2 weeks, 3 months, 6 months and 12 months. At 12 months, clinical examination, lumbar puncture and retrograde catheter venography with manometry will be performed to evaluate the patency of the treated sinus and the absence of trans-stent pressure gradient. Subjects will be consented to be clinically followed annually for up to 5 years.
Patient is placed under general anesthesia. From femoral vein access, a standard guide-catheter is advanced in the internal jugular vein (on the side considered for stenting). The sigmoid then transverse sinus is catheterized with a microcatheter and guide-wire and an exchange guide-wire is placed in the superior sagittal sinus. The River stent delivery catheter is advanced over the exchange guide-wire in the sigmoid then transverse sinus up to the torcula. The River stent is deployed to cover the entire transverse sinus and the proximal half of the sigmoid sinus. The catheters are removed and hemostasis obtained by using a closure device or manual compression. The patient is kept overnight in the hospital for observation.
Baptist Health
Jacksonville, Florida, United States
UB Neurosurgery
Buffalo, New York, United States
Northwell Health
Manhasset, New York, United States
Weill Cornell Medicine
New York, New York, United States
Major Adverse Event (MAE)
The MAE is a composite of the following: Moderate or severe stroke (NIH stroke scale \> 3) Neurological death Perforation of sinus or cerebral vein Thrombosis of sinus or cerebral vein Device distal embolization Need for target lesion revascularization or need for IIH alternate procedure (cerebrospinal fluid shunting or optic nerve sheath fenestration)
Time frame: 12 months
Clinical improvement with no restenosis of the venous sinus
The primary probable benefit endpoint is a composite of: 1. Absence of significant stenosis (defined as \>50% stenosis of reference vessel diameter) of the main dural venous sinus on retrograde catheter venography (RCV) AND 2. Trans-stent pressure gradient (measured during the RCV) \< 8 mm Hg AND 3. Clinically relevant improvement in the main clinical outcome per specific inclusion criteria (headache or ophthalmic) and stabilization or better of the other
Time frame: 12 months
Individual components of MAE.
Components of MAE will be reported as individual event rates.
Time frame: 12 months
Cerebrospinal fluid (CSF) opening pressure at 12 months
CSF opening pressure will be measured via lumbar puncture in the lateral decubitus position.
Time frame: 12 months
Stent patency at 12 months
Stent patency will be assessed by retrograde catheter venography. Patency is defined as absence of significant (\>50%) stenosis
Time frame: 12 months
Medications
Change in IIH medications and dosage at 12 months compared to baseline
Time frame: 12 months
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Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
Headaches
Change in headaches assessed using the Headache Impact Test (HIT-6) scale (minimum score 36, maximum 78; higher value represents worse headache) at 12 months compared to baseline.
Time frame: 12 months
Papilledema
Change in papilledema grading using Frisen scale (Stage 0 to 5; stage 0 represents no papilledema and is the best outcome) at 12 months compared to baseline.
Time frame: 12 months
Visual acuity
Change in visual acuity using the Early treatment Diabetic Retinopathy (ETDRS) chart at 12 months compared to baseline.
Time frame: 12 months
Retinal Nerve Fiber Layer Thickness
Change in retinal nerve fiber layer thickness measured using Optical Coherence Tomography (OCT) at 12 months compared to baseline.
Time frame: 12 months
Tinnitus
Change in the intensity of tinnitus evaluated on the Tinnitus Functional Index (TFI) score (overall score; minimum 0, maximum 100; 100 is the worst tinnitus with the worst negative impact) at 12 months compared to baseline.
Time frame: 12 months
Quality of Life SF-12
Change in quality of life assessed with the Short Form health survey 12 items (SF-12) at 12 months compared to baseline
Time frame: 12 months
Quality of Life NEI-VFQ-25
Change in quality of life assessed with the National Eye Institute - Visual Functioning Questionnaire - 25 at 12 months compared to baseline.
Time frame: 12 months