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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.
Full description
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.
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:
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.
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Inclusion criteria
Subjects must meet all of the following criteria to be eligible for participation in the study:
Exclusion criteria
Subject must be excluded from participation in this study if any of the following criteria are met
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39 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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