Clinical trial NCT03373292: Endovascular Stenting Treatment for Patients With Internal Jugular Vein Stenosis
Official title: Evaluation of the Feasibility, Safety and Efficacy of Venous Stenting for Internal Jugular Vein Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Stent Stenosis
Intracranial Hypertension
Headache
Tinnitus
Papilledema
Visual Impairment
Keywords: Stenting
Jugular vein stenosis
Intracranial hypertension
Headache
Tinnitus
Papilledema
Visual impairment
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correction of internal jugular vein stenosis (IJVS) and abnormal collateral veins
timeFrame: baseline, 1, 6 and 12 months
Secondary outcomes:
measure: The evaluation of cerebral spinal fluid (CSF) pressure
timeFrame: baseline, immediately post-stenting, within 1 month
measure: The evaluation of headache
timeFrame: baseline, within 1, 6 and 12 months
measure: The evaluation of tinnitus
timeFrame: baseline, within 1, 6 and 12 months
measure: The evaluation of the severity of papilledema and other ophthalmological conditions
timeFrame: baseline, within 1, 6 and 12 months
measure: Changes in cerebral white matter (WM)
timeFrame: baseline, within 12 months
measure: The evaluation of cognitive function
timeFrame: baseline, within 12 months
measure: The evaluation of mental status
timeFrame: baseline, within 12 months
measure: The evaluation of sleeping status
timeFrame: baseline, within 12 months
measure: The extent of disability or dependence in the daily activities
timeFrame: baseline, within 12 months
measure: Percentage of participants with abnormal lab values
timeFrame: baseline, within 12 months
measure: Percentage of participants with procedure-related and/or stenting-related complications
timeFrame: within 12 months
measure: The incidence of all cause mortality
timeFrame: within 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Xuanwu Hosptial, Capital Medical University
name: Xuming Ji, MD, PhD
role: STUDY_DIRECTOR
affiliation: Xuanwu Hosptial, Capital Medical University
name: Ran Meng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou D, Meng R, Zhang X, Guo L, Li S, Wu W, Duan J, Song H, Ding Y, Ji X. Intracranial hypertension induced by internal jugular vein stenosis can be resolved by stenting. Eur J Neurol. 2018 Feb;25(2):365-e13. doi: 10.1111/ene.13512. Epub 2017 Dec 7.
citation: Higgins JN, Garnett MR, Pickard JD, Axon PR. An Evaluation of Styloidectomy as an Adjunct or Alternative to Jugular Stenting in Idiopathic Intracranial Hypertension and Disturbances of Cranial Venous Outflow. J Neurol Surg B Skull Base. 2017 Apr;78(2):158-163. doi: 10.1055/s-0036-1594238. Epub 2016 Nov 23.
citation: Spitze A, Malik A, Lee AG. Surgical and endovascular interventions in idiopathic intracranial hypertension. Curr Opin Neurol. 2014 Feb;27(1):69-74. doi: 10.1097/WCO.0000000000000049.
citation: Ding J, Liu Y, Li X, Chen Z, Guan J, Jin K, Wang Z, Ding Y, Ji X, Meng R. Normobaric Oxygen May Ameliorate Cerebral Venous Outflow Disturbance-Related Neurological Symptoms. Front Neurol. 2020 Nov 13;11:599985. doi: 10.3389/fneur.2020.599985. eCollection 2020.