Venous Sinus Stenosis Clinical Trial
Official title:
Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)
The aim of this study is to assess the efficacy of stent implantation versus medical therapy on idiopathic intracranial hypertension with venous sinus stenosis.
Status | Recruiting |
Enrollment | 74 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Subject Eligibility Criteria 1. Diagnosis of IIH by modified Dandy criteria for more than 2 months 2. Lumbar puncture opening pressure =250 mmH2O within 6 weeks before enrollment 3. Normal cerebrospinal fluid (CSF) composition 4. Neuroimaging showing normal brain parenchyma without hydrocephalus, mass, or any structural lesion and no evidence of meningeal enhancement on CT or MRI 5. Localized venous sinus stenosis (VSS) with stenotic degree = 50% on DSA, and pressure gradient across stenosis = 8 mmHg 6. Patients or their relatives signed written informed consent - Ophthalmic Eligibility Criteria: 1. At least one eye had the presence of papilledema 2. At least one eye of visual field loss: PMD ranging from - 2dB and below; decreased visual function on automated perimetry was reproducible with a false-positive rate of no more than 15% 3. Visual acuity above 20 / 200 (= 39 letters) Exclusion Criteria: - Subject Exclusion Criteria 1. Previous surgery for IIH, including optic nerve sheath fenestration (ONSF), CSF shunting, decompressive craniectomy or venous sinus stenting 2. Visual loss due to other etiologies (eg, retinal drusen, retinal and optic neuropathy, cataracts, etc) 3. Other condition requiring the use of diuretics, steroids or other drugs to reduce intracranial pressure 4. DSA showed diffused venous sinus stenosis, cortical or deep vein stenosis 5. A history of severe thyroid disease and iodine allergy 6. Pregnant or lactating women 7. Severe cardiopulmonary, liver or kidney failure 8. Known hereditary or acquired haemorrhagic diathesis 9. Known hereditary or acquired thrombophilia 10. Platelet counts or coagulation abnormality 11. Major surgery or severe trauma or any traumatic brain injury within the previous 14 days 12. A history of cerebral hemorrhage, arteriovenous malformation, intracranial aneurysm or tumor 13. Other life threatening illness (eg, advanced cancer) likely to lead to death within a few months; the physical, psychological and social status of patients may affect follow-up (eg, drug addiction, advanced malignant disease, no telephone, no family, etc); cannot tolerate general anesthesia 14. Increased intracranial pressure due to other secondary factors - Ophthalmic Exclusion Criteria: 1. Current intraocular pressure > 28mmHg or previous intraocular pressure > 30mmHg 2. Refractive error spherical power greater than -6.0D or +6.0D and astigmatism greater than 3.0D, except for the following cases: 1. Myopia of - 6.0D to - 8.0D with the following: 1)There was no myopia related disease that can lead to decreased vision under the eyeground microscope (eg, scleral staphyloma, retinal thinning at the posterior pole, and moderate to severe disc tilt); 2) The patient wore contact lenses of appropriate degree for all visual field examinations. 2. Hyperopia of +6.0D to +8.0D with the following: 1) The presence of a well characterized peri optic disc edematous halo, as opposed to crowded small optic discs or other features of decreased visual acuity associated with hyperopic changes, was at the discretion of the site investigator or reading center leader (or his designee); 2) The patient wore contact lenses of appropriate degree for all visual field examinations. 3. Examination visible or past medical history known to have large optic disc drusen (persistent optic disc edema can present with small optic disc drusen, as low numbers are acceptable for inclusion and to be determined by the investigator to be unrelated to vision loss) |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tiantan Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tiantan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Functional health status and quality of life:EuroQol five dimensions questionnaire (EQ-5D,0-100,higher scores mean a better outcome) | The change in functional health status and quality of life measured by EuroQol five dimensions questionnaire (EQ-5D) from baseline to 6 months | 6 months | |
Other | Cost-effectiveness analysis (mean costs per patient) | The indicator of cost-effectiveness analysis refers to the mean costs per patient. | 6 months | |
Other | Cost-effectiveness analysis (quality-adjusted life years) | The indicator of cost-effectiveness analysis refers to the quality-adjusted life years. | 6 months | |
Other | Cost-effectiveness analysis (the cost saving per extra patient with a good outcome) | The indicator of cost-effectiveness analysis refers to the cost saving per extra patient with a good outcome. | 6 months | |
Other | Cost-effectiveness analysis (the cost saving per additional quality-adjusted life year) | The indicator of cost-effectiveness analysis refers to the cost saving per additional quality-adjusted life year. | 6 months | |
Primary | Perimetric Mean Deviation (PMD) | The change in perimetric mean deviation (PMD) from baseline to 6 month in the eye with the most severe visual loss at baseline. | 6 months | |
Secondary | Cerebrospinal Fluid (CSF) Opening Pressure | The change in intracranial pressure measured by lumbar puncture opening pressure from baseline to 6 months. | 6 months | |
Secondary | Papilledema Grade: Frisén grade(0-5 scores,and higher scores mean worse outcome) | The change in papilledema measured by Frisén grade from baseline to 6 months | 6 months | |
Secondary | Retinal Nerve Fiber Layer Thickness | The change in thickness of retinal nerve fiber layer measured by optical coherence tomography (OCT) from baseline to 6 months. | 6 months | |
Secondary | Total Retinal Thickness | The change in thickness of total retina measured by optical coherence tomography (OCT) from baseline to 6 months. | 6 months | |
Secondary | Visual Acuity: National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25, minimum and maximum values: 0-100 points, higher scores mean a better visual function) | The change in vision measured by National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) from baseline to 6 months. | 6 months | |
Secondary | Visual Acuity: 10-item neuro-ophthalmic supplement to the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) (minimum and maximum values: 0-100 points, higher scores mean a better visual function) | The change in vision measured by 10-item neuro-ophthalmic supplement to the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25)from baseline to 6 months. | 6 months | |
Secondary | Headache: Headache Impact Test-6 (HIT-6, minimum and maximum values: 36-78 points, higher scores mean greater headache severity) | The change in headache measured by Headache Impact Test-6 (HIT-6) questionnaire from baseline to 6 months. | 6 months | |
Secondary | Pulsatile tinnitus: Tinnitus Handicap Inventory (THI, minimum and maximum values: 0-100 points, higher scores mean more serious tinnitus disability) | The change in pulsatile tinnitus from baseline to 6 months;pulsatile tinnitus was assessed using the Tinnitus Handicap Inventory (THI), which is a self-report measure that can be used in a busy clinical practice to quantify the impact of tinnitus on daily living. | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02734576 -
Venous Sinus Stenting To Treat Intractable Pulsatile Tinnitus Caused By Venous Sinus Stenosis
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N/A |