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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.
Idiopathic Intracranial Hypertension
Venous sinus stenting (Serenity River)
Not yet recruiting
Serenity Medical, Inc.
Published on BioPortfolio: 2018-06-19T02:41:11-0400
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To determine the relationship between normal physiologic and pathologic venous sinus pressures in patients with idiopathic intracranial hypertension (IIH), which is poorly understood.
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The diagnostic criteria for headache attributable to cranial venous sinus stenting were first formalized in the recently published third edition of the International Classification of Headache Disorde...
Internal jugular vein stenosis (IJVS) results in poor venous outflow and can result in intracranial hypertension. Venous stenting has become a debated topic for correction of this pathology.
Rare vascular anomaly involving a communication between the intracranial and extracranial venous circulation via diploe, the central spongy layer of cranial bone. It is often characterized by dilated venous structures on the scalp due to abnormal drainage from the intracranial venous sinuses. Sinus pericranii can be congenital or traumatic in origin.
Formation or presence of a blood clot (THROMBUS) in the CRANIAL SINUSES, large endothelium-lined venous channels situated within the SKULL. Intracranial sinuses, also called cranial venous sinuses, include the superior sagittal, cavernous, lateral, petrous sinuses, and many others. Cranial sinus thrombosis can lead to severe HEADACHE; SEIZURE; and other neurological defects.
An acquired or spontaneous abnormality in which there is communication between CAVERNOUS SINUS, a venous structure, and the CAROTID ARTERIES. It is often associated with HEAD TRAUMA, specifically basilar skull fractures (SKULL FRACTURE, BASILAR). Clinical signs often include VISION DISORDERS and INTRACRANIAL HYPERTENSION.
An intracranial or rarely intraspinal suppurative process invading the space between the inner surface of the DURA MATER and the outer surface of the ARACHNOID. Bacteria and other pathogenic organisms may gain entrance to the subdural space from the FRONTAL SINUS; ETHMOID SINUS; middle ear (EAR, MIDDLE); MASTOID; or as the result of CRANIOCEREBRAL TRAUMA or NEUROSURGICAL PROCEDURES. This condition may be associated with intracranial sinus thrombosis (SINUS THROMBOSIS, INTRACRANIAL). Circumscribed collections of purulent material in the subdural space are referred to as subdural abscesses. (From Adams et al., Principles of Neurology, 6th ed, p709)
Increased pressure within the cranial vault. This may result from several conditions, including HYDROCEPHALUS; BRAIN EDEMA; intracranial masses; severe systemic HYPERTENSION; PSEUDOTUMOR CEREBRI; and other disorders.
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