Venous Sinus Stenting With the River Stent in IIH
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|ClinicalTrials.gov Identifier: NCT03556085|
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : November 21, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Intracranial Hypertension||Device: Venous sinus stenting (Serenity River)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, multicenter, single arm, open label clinical study|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of the Serenity River Stent System to Treat Idiopathic Intracranial Hypertension|
|Actual Study Start Date :||August 24, 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2020|
Experimental: Venous sinus stenting
Subjects will have stenting of the transverse-sigmoid sinus
Device: Venous sinus stenting (Serenity River)
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.
- Major Adverse Event (MAE) [ Time Frame: 12 months ]
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)
- Clinical improvement with no restenosis of the venous sinus [ Time Frame: 12 months ]
The primary probable benefit endpoint is a composite of:
- Absence of significant stenosis (defined as >50% stenosis of reference vessel diameter) of the main dural venous sinus on retrograde catheter venography (RCV) AND
- Trans-stent pressure gradient (measured during the RCV) < 8 mm Hg AND
- Clinically relevant improvement in the main clinical outcome per specific inclusion criteria (headache or ophthalmic) and stabilization or better of the other
- Individual components of MAE. [ Time Frame: 12 months ]Components of MAE will be reported as individual event rates.
- Cerebrospinal fluid (CSF) opening pressure at 12 months [ Time Frame: 12 months ]CSF opening pressure will be measured via lumbar puncture in the lateral decubitus position.
- Stent patency at 12 months [ Time Frame: 12 months ]Stent patency will be assessed by retrograde catheter venography. Patency is defined as absence of significant (>50%) stenosis
- Medications [ Time Frame: 12 months ]Change in IIH medications and dosage at 12 months compared to baseline
- Headaches [ Time Frame: 12 months ]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.
- Papilledema [ Time Frame: 12 months ]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.
- Visual acuity [ Time Frame: 12 months ]Change in visual acuity using the Early treatment Diabetic Retinopathy (ETDRS) chart at 12 months compared to baseline.
- Retinal Nerve Fiber Layer Thickness [ Time Frame: 12 months ]Change in retinal nerve fiber layer thickness measured using Optical Coherence Tomography (OCT) at 12 months compared to baseline.
- Tinnitus [ Time Frame: 12 months ]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.
- Quality of Life SF-12 [ Time Frame: 12 months ]Change in quality of life assessed with the Short Form health survey 12 items (SF-12) at 12 months compared to baseline
- Quality of Life NEI-VFQ-25 [ Time Frame: 12 months ]Change in quality of life assessed with the National Eye Institute - Visual Functioning Questionnaire - 25 at 12 months compared to baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556085
|Contact: Yves P Gobin, MDfirstname.lastname@example.org|
|Contact: Sew-Wah Tay, PhDemail@example.com|
|United States, New York|
|Buffalo, New York, United States, 14203|
|Contact: Jennifer Gay 716-929-9643 firstname.lastname@example.org|
|Weill Cornell Medicine||Recruiting|
|New York, New York, United States, 10065|
|Contact: Athos Patsalides, MD 212-746-2821 email@example.com|
|United States, Oregon|
|Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Kelsey Launchbury 503-418-1722 firstname.lastname@example.org|
|Principal Investigator:||Athos Patsalides, MD||Weill Cornell Medicine|