Endovascular Stenting Treatment for Patients With Internal Jugular Vein Stenosis

NCT03373292 | Unknown Phase 1

• 1 other identifier: Stenting2018-IJVS
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Stent Stenosis; Intracranial Hypertension; Headache; Tinnitus; Papilledema; Visual Impairment

Keywords

Stenting; Jugular vein stenosis; Intracranial hypertension; Headache; Tinnitus; Papilledema; Visual impairment

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline, 1, 6 and 12 months

Secondary Outcomes (12)

• The evaluation of cerebral spinal fluid (CSF) pressure

  baseline, immediately post-stenting, within 1 month

• The evaluation of headache

  baseline, within 1, 6 and 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

• Changes in cerebral white matter (WM)

  baseline, within 12 months

Study Arms (2)

Venous stenting (Group-1)

EXPERIMENTAL

Patients in this group will undergo venous stenting treatment at once after enrollment.

Procedure: Venous stenting for internal jugular vein stenosis

Stenting one-month after routine medical treatment (Group-2)

EXPERIMENTAL

Patients in this group will undergo routine medical treatment for one month, followed by venous stenting intervention.

Procedure: One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis

Interventions

Venous stenting for internal jugular vein stenosis PROCEDURE

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).

Venous stenting (Group-1)

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

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.

Stenting one-month after routine medical treatment (Group-2)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Related Publications (4)

• 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.

  PMID: 29114973 BACKGROUND

• 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.

  PMID: 28321380 BACKGROUND

• 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.

  PMID: 24296639 BACKGROUND

• 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.

  PMID: 33281736 DERIVED

MeSH Terms

Conditions

Intracranial Hypertension; Headache; Tinnitus; Papilledema; Vision Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases

Study Officials

• Xuming Ji, MD, PhD

  Xuanwu Hosptial, Capital Medical University

  STUDY DIRECTOR

• Ran Meng, MD, PhD

  Xuanwu Hosptial, Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President, Professor, Xuanwu Hospital

Study Record Dates

• First Submitted: December 3, 2017
• First Posted: December 14, 2017
• Study Start: January 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: April 1, 2020
• Last Updated: December 14, 2017

Record last verified: 2017-12