Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)

Обзор

The aim of this study is to assess the efficacy of stent implantation versus medical therapy on idiopathic intracranial hypertension with venous sinus stenosis.

Подробное описание

The SIMPLE is a multicentered, prospective, randomized, open-label, blinded end-point clinical trial. A total of 74 patients with idiopathic intracranial hypertension (IIH) and venous sinus stenosis (VSS) for more than 2 months will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups (stenting or medical therapy) after offering informed content.

Вмешательства

• Процедура Stent Implantation
  Aspirin (100 mg) and clopidogrel (75 mg) were administered 3-5 days before endovascular treatment. The endovascular procedure was performed under general anesthesia. Intravenous heparin was administered during the stent procedure to increase the activated clotting time to \> 250 s. An 8F guiding catheter was delivered to the internal jugular vein near the skull base. A 6F Navien intermediate guide catheter was then placed into the distal transverse sinus near the torcula through the 8F guiding c
• Препарат Acetazolamide-based medical therapy
  The medical treatment consisted of acetazolamide (0.5-4 g/day) and short-term mannitol (bolus of 0.25-1 g/kg body weight) for a duration of about 1 week or repeated lumbar punctures to reduce intracranial pressure (20 mL each), as well as analgesics for headaches. The initial dosage of acetazolamide was 0.5 g daily in two divided doses, followed by dosage increases of one tablet every week up to a maximum dosage of 4 g/day. The dosage escalation was stopped if the participant had papilledema gra
• Поведенческое Weight loss
  The weight loss program included a low-calorie diet (≤425 kcal/day) with a target weight loss of approximately 5-10%.

Первичные конечные точки

• Perimetric Mean Deviation (PMD) [Срок оценки: 6 months]

Вторичные конечные точки (8)

• Cerebrospinal Fluid (CSF) Opening Pressure [Срок оценки: 6 months]
• Papilledema Grade: Frisén grade(0-5 scores,and higher scores mean worse outcome) [Срок оценки: 6 months]
• Retinal Nerve Fiber Layer Thickness [Срок оценки: 6 months]
• Total Retinal Thickness [Срок оценки: 6 months]
• 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) [Срок оценки: 6 months]
• 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) [Срок оценки: 6 months]
• Headache: Headache Impact Test-6 (HIT-6, minimum and maximum values: 36-78 points, higher scores mean greater headache severity) [Срок оценки: 6 months]
• Pulsatile tinnitus: Tinnitus Handicap Inventory (THI, minimum and maximum values: 0-100 points, higher scores mean more serious tinnitus disability) [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Subject Eligibility Criteria

• Diagnosis of IIH by modified Dandy criteria about for more than 2 months
• Lumbar puncture opening pressure ≥250 mmH₂O within 6 weeks before enrollment
• Normal cerebrospinal fluid (CSF) composition
• Neuroimaging showing normal brain parenchyma without hydrocephalus, mass, or any structural lesion and no evidence of meningeal enhancement on CT or MRI
• Localized venous sinus stenosis (VSS) with stenotic degree ≥ 50% on DSA, and pressure gradient across stenosis ≥ 8 mmHg
• Patients or their relatives signed written informed consent
• Ophthalmic Eligibility Criteria:

• At least one eye had the presence of papilledema
• 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%
• Visual acuity above 20 / 200 (≥ 39 letters)

Критерии исключения

• Subject Exclusion Criteria

• Previous surgery for IIH, including optic nerve sheath fenestration (ONSF), CSF shunting, decompressive craniectomy or venous sinus stenting
• Progressive or rapid visual loss needed urgent surgical intervention; if delay>24-48 h consider interim lumbar drain (for rapid visual loss only).Surgical options to consider: CSF diversion or optic nerve sheath fenestration
• Visual loss due to other etiologies (eg, retinal drusen, retinal and optic neuropathy, cataracts, etc)
• Other condition requiring the use of diuretics, steroids or other drugs to reduce intracranial pressure
• DSA showed diffused venous sinus stenosis, cortical or deep vein stenosis
• A history of severe thyroid disease and iodine allergy
• Pregnant or lactating women
• Severe cardiopulmonary, liver or kidney failure
• Known hereditary or acquired haemorrhagic diathesis
• Known hereditary or acquired thrombophilia
• Platelet counts or coagulation abnormality
• Major surgery or severe trauma or any traumatic brain injury within the previous 14 days
• A history of cerebral hemorrhage, arteriovenous malformation, intracranial aneurysm or tumor
• 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
• Increased intracranial pressure due to other secondary factors
• Ophthalmic Exclusion Criteria:

• Current intraocular pressure > 28mmHg or previous intraocular pressure > 30mmHg
• Refractive error spherical power greater than -6.0D or +6.0D and astigmatism greater than 3.0D, except for the following cases:

• 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.
• 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.
• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital — Пекин

Идентификаторы

NCT: NCT05707442 · HX-A-2022042

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗