Endovascular Stenting Treatment for Patients With Internal Jugular Vein Stenosis

Phase 1

• Conditions: Stent Stenosis; Tinnitus; Papilledema; Visual Impairment; Intracranial Hypertension; Headache
• Interventions: Procedure: Venous stenting for internal jugular vein stenosis; Procedure: One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis

• Registration Number: NCT03373292
• Lead Sponsor: Capital Medical University

Brief Summary

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).

Detailed Description

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 Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-03
• Study First Submitted QC: 2017-12-08
• Last Update Submitted: 2017-12-08
• Study First Posted: 2017-12-14
• Last Update Posted: 2017-12-14
• Study Start: 2018-01
• Primary Completion: 2020-01
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Venous stenting (Group-1)	Venous stenting for internal jugular vein stenosis	Patients in this group will undergo venous stenting treatment at once after enrollment.
Stenting one-month after routine medical treatment (Group-2)	One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis	Patients in this group will undergo routine medical treatment for one month, followed by venous stenting intervention.

Primary Outcome Measures

Name	Time	Method
Correction of internal jugular vein stenosis (IJVS) and abnormal collateral veins	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).

Secondary Outcome Measures

Name	Time	Method
The evaluation of mental status	baseline, within 12 months	Mental status will be assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS score ranges between 0 and 21 for either anxiety or depression. A cut-off point of 8/21 is indicated for anxiety or depression.
The evaluation of cerebral spinal fluid (CSF) pressure	baseline, immediately post-stenting, within 1 month	CSF pressure will be assessed by lumbar puncture.
The evaluation of sleeping status	baseline, within 12 months	Sleeping status will be assessed with the Pittsburgh Sleep Quality Index (PSQI) and/or the Athens Insomnia Scale (AIS). The PSQI score provides an overall score ranging from 0 to 21, where a cut-off score of ≤5 denotes a healthier sleep quality. The AIS score provides an overall score ranging from 0 to 24, where a cut-off score of \<6 denotes a healthier sleep quality.
The incidence of all cause mortality	within 12 months	Death secondary to any reasons
The extent of disability or dependence in the daily activities	baseline, within 12 months	The extent of disability will be assessed by the modified Rankin Scale (mRS). (Score 0-no symptoms; score 1-no significant disability; score 2-slight disability; score 3-moderate disability; score 4-moderately severe disability; score 5-severe disability; score 6-dead.)
Percentage of participants with abnormal lab values	baseline, within 12 months	Lab examinations such as hepatic and renal function, blood and urine routine will be recorded.
The evaluation of headache	baseline, within 1, 6 and 12 months	The intensity of headache will be assessed with the Headache Impact Test-6 (HIT-6).
The evaluation of tinnitus	baseline, within 1, 6 and 12 months	The severity of tinnitus will be assessed by the Tinnitus Handicap Inventory Questionnaire (THIQ).
The evaluation of the severity of papilledema and other ophthalmological conditions	baseline, within 1, 6 and 12 months	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.
Percentage of participants with procedure-related and/or stenting-related complications	within 12 months
Changes in cerebral white matter (WM)	baseline, within 12 months	The characteristics of WM will be evaluated by Magnetic Resonance Imaging (MRI).
The evaluation of cognitive function	baseline, within 12 months	Cognitive function will be assessed with the Mini-Mental State Examination (MMSE), the Montreal Cognitive Assessment (MoCA) and/or the Modified Telephone Interview for Cognitive Status (TICS-M).