Endovascular Stenting Treatment for Patients With Internal Jugular Vein Stenosis

Capital Medical University60 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stent Stenosis Intracranial Hypertension Headache Tinnitus Papilledema Visual Impairment

Interventions

Venous stenting for internal jugular vein stenosisPROCEDURE

After confirming the diagnosis of IJVS by Jugular Vein Doppler Ultrasound, Magnetic Resonance Venography (MRV) and/or Computed Tomography Venography (CTV), and excluding external compression-induced stenosis as well as other causes of intracranial pressure elevation, patients will be divided into two groups randomly (30 for each group: group-1 and group-2). Patients in Group-1 will receive Digital Subtraction Angiography (DSA) immediately after enrollment, and trans-stenotic pressures (∆MPGs) will be measured, balloon angioplasty bridging venous stenting will be performed when their ∆MPGs of jugular veins are equal to or greater than 5.44 cmH₂O (4 mmHg).

One-month routine medical treatment followed by venous stenting for internal jugular vein stenosisPROCEDURE

Patients in Group-2 will receive routine medical treatment for one month. Afterwards, they will undergo DSA (the procedure is the same as that in Group-1). Notably, patients in Group-2 with medical uncontrolled intracranial hypertension will be provided stenting of their jugular veins at any time during the one-month routine medical treatment, in attempt to reduce their intracranial pressure and ameliorate visual damages in time.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ranging from 18 to 80 years of age, both genders. 2. Patients diagnosed with IJVS surrounded by abnormally and tortuous collateral veins verified by MRV, CTV and/or DSA. 3. Pressure gradient across the stenotic segments is equal to or greater than 4 mmHg. 4. Intracranial hypertension associated manifestations cannot be satisfactorily controlled by conservative or non-surgical therapies. 5. Informed consent obtained from the patient or his/her health care proxy, able to cooperate follow-up visits. Exclusion Criteria: 1. External osseous impingement associated IJVS. 2. Contraindication to iodinated contrasts. 3. Contraindication to general anesthesia. 4. Contraindication to standard medical therapy such as Aspirin, Clopidogrel or anticoagulants. 5. Intracranial abnormalities such as tumor, abscess, vascular malformation, cerebral venous sinus stenosis or thrombosis. 6. Previous history of major surgeries within 30 days prior to inclusion, or scheduled for any of the procedures within 12 months after inclusion. 7. Severe hematological, hepatic or renal dysfunctions. 8. Current or having a history of chronic physical diseases or mental disorders. 9. Pregnant or lactating women. 10. Life expectancy \< 1 year due to concomitant life-threatening illness. 11. Patients unlikely to be compliant with intervention or return for follow-up visits. 12. No signed consent from the patient or available legally authorized representatives. 13. Patients recruited to other clinical trials with medications or devices, which may affect the outcome of this study.

Outcomes

Primary Outcomes

Correction of internal jugular vein stenosis (IJVS) and abnormal collateral veins

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).

Time frame: baseline, 1, 6 and 12 months

Secondary Outcomes

The evaluation of cerebral spinal fluid (CSF) pressure

CSF pressure will be assessed by lumbar puncture.

Time frame: baseline, immediately post-stenting, within 1 month

The evaluation of headache

The intensity of headache will be assessed with the Headache Impact Test-6 (HIT-6).

Time frame: baseline, within 1, 6 and 12 months

The evaluation of tinnitus

The severity of tinnitus will be assessed by the Tinnitus Handicap Inventory Questionnaire (THIQ).

Time frame: baseline, within 1, 6 and 12 months

The evaluation of the severity of papilledema and other ophthalmological conditions

The severity of papilledema will be assessed based on Frisén papilledema grade (FPG) criteria; the assessment of other ophthalmological conditions including visual acuity, visual ﬁeld, and fundus etc. will be based on visual acuity chart, visual fields picture, and optical coherence tomography (OCT) etc.

Time frame: baseline, within 1, 6 and 12 months

Changes in cerebral white matter (WM)

The characteristics of WM will be evaluated by Magnetic Resonance Imaging (MRI).

Time frame: baseline, within 12 months

Central Contacts

Ran Meng, MD, PhD

CONTACT

+86-10-83198952 Ranmeng2011@pku.org.cn

Da Zhou, MD, PhD Candidate

CONTACT

+86-10-83198952 popdoctor@foxmail.com

Data from ClinicalTrials.gov

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