Evaluation of the Feasibility, Safety and Efficacy of Venous Stenting for Internal Jugular Vein Stenosis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 主要终点
- Correction of internal jugular vein stenosis (IJVS) and abnormal collateral veins
研究概览
简要总结
This is a prospective, randomized, single-center clinical study aiming to explore the safety and efficacy of venous stenting for patients with internal jugular vein stenosis (IJVS).
详细描述
The role of isolated non-thrombotic IJVS in idiopathic intracranial hypertension has recently gained a vested interest. Compared with venous sinus stenosis, isolated IJVS at extracranial segments is more concealed and likely to be neglected, leading to misdiagnosis or treatment delay and subsequent exacerbation of clinical outcomes. Stenting seems to hold a potential of addressing the intracranial pressure elevation-associated clinical issues from etiological level, especially after medical therapy failure. The complications of stenting such as ipsilateral headache, restenosis, intra-stent thrombosis and hemorrhage have beem demonstrated in the settings of intracranial sinus obstruction and osseous impingement-associated IJVS, particularly bony structures between the styloid process and lateral mass of C1 that constrain the IJV. Nevertheless, so far, to the best of our knowledge, few or no stenting related adverse events have been found in isolated IJVS patients with venous stent implantation.
In this study, 60 patients satisfied with the inclusion criteria will be enrolled and randomly allocated into two groups. The safety and efficacy of stenting in patients with non-osseous impingement-mediated IJVS will be analyzed. Other medical interventions will be guaranteed according to the best medical judgment from clinical practitioners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranging from 18 to 80 years of age, both genders.
- •Patients diagnosed with IJVS surrounded by abnormally and tortuous collateral veins verified by MRV, CTV and/or DSA.
- •Pressure gradient across the stenotic segments is equal to or greater than 4 mmHg.
- •Intracranial hypertension associated manifestations cannot be satisfactorily controlled by conservative or non-surgical therapies.
- •Informed consent obtained from the patient or his/her health care proxy, able to cooperate follow-up visits.
排除标准
- •External osseous impingement associated IJVS.
- •Contraindication to iodinated contrasts.
- •Contraindication to general anesthesia.
- •Contraindication to standard medical therapy such as Aspirin, Clopidogrel or anticoagulants.
- •Intracranial abnormalities such as tumor, abscess, vascular malformation, cerebral venous sinus stenosis or thrombosis.
- •Previous history of major surgeries within 30 days prior to inclusion, or scheduled for any of the procedures within 12 months after inclusion.
- •Severe hematological, hepatic or renal dysfunctions.
- •Current or having a history of chronic physical diseases or mental disorders.
- •Pregnant or lactating women.
- •Life expectancy < 1 year due to concomitant life-threatening illness.
- •Patients unlikely to be compliant with intervention or return for follow-up visits.
- •No signed consent from the patient or available legally authorized representatives.
- •Patients recruited to other clinical trials with medications or devices, which may affect the outcome of this study.
研究组 & 干预措施
Venous stenting (Group-1)
Patients in this group will undergo venous stenting treatment at once after enrollment.
干预措施: Venous stenting for internal jugular vein stenosis (Procedure)
Stenting one-month after routine medical treatment (Group-2)
Patients in this group will undergo routine medical treatment for one month, followed by venous stenting intervention.
干预措施: One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis (Procedure)
结局指标
主要结局
Correction of internal jugular vein stenosis (IJVS) and abnormal collateral veins
时间窗: baseline, 1, 6 and 12 months
The status of internal jugular vein blood flow and collateral veins will be evaluated by imaging modalities, mainly including: Jugular Vein Doppler Ultrasound, Magnetic Resonance Venography (MRV), Computed Tomography Venography (CTV) and Digital Subtraction Angiography (DSA).
次要结局
- The evaluation of mental status(baseline, within 12 months)
- The evaluation of cerebral spinal fluid (CSF) pressure(baseline, immediately post-stenting, within 1 month)
- The evaluation of sleeping status(baseline, within 12 months)
- The incidence of all cause mortality(within 12 months)
- The extent of disability or dependence in the daily activities(baseline, within 12 months)
- Percentage of participants with abnormal lab values(baseline, within 12 months)
- The evaluation of headache(baseline, within 1, 6 and 12 months)
- The evaluation of cognitive function(baseline, within 12 months)
- The evaluation of tinnitus(baseline, within 1, 6 and 12 months)
- The evaluation of the severity of papilledema and other ophthalmological conditions(baseline, within 1, 6 and 12 months)
- Percentage of participants with procedure-related and/or stenting-related complications(within 12 months)
- Changes in cerebral white matter (WM)(baseline, within 12 months)
研究者
Ji Xunming
Vice President, Professor, Xuanwu Hospital
Capital Medical University