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Endovascular Stenting Treatment for Patients With Internal Jugular Vein Stenosis

Primary Purpose

Stent Stenosis, Intracranial Hypertension, Headache

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Venous stenting for internal jugular vein stenosis
One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stent Stenosis focused on measuring Stenting, Jugular vein stenosis, Intracranial hypertension, Headache, Tinnitus, Papilledema, Visual impairment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Venous stenting (Group-1)

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

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    The evaluation of cerebral spinal fluid (CSF) pressure
    CSF pressure will be assessed by lumbar puncture.
    The evaluation of headache
    The intensity of headache will be assessed with the Headache Impact Test-6 (HIT-6).
    The evaluation of tinnitus
    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
    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.
    Changes in cerebral white matter (WM)
    The characteristics of WM will be evaluated by Magnetic Resonance Imaging (MRI).
    The evaluation of cognitive function
    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).
    The evaluation of mental status
    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 sleeping status
    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 extent of disability or dependence in the daily activities
    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
    Lab examinations such as hepatic and renal function, blood and urine routine will be recorded.
    Percentage of participants with procedure-related and/or stenting-related complications
    The incidence of all cause mortality
    Death secondary to any reasons

    Full Information

    First Posted
    December 3, 2017
    Last Updated
    December 8, 2017
    Sponsor
    Capital Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03373292
    Brief Title
    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

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2018 (Anticipated)
    Primary Completion Date
    January 2020 (Anticipated)
    Study Completion Date
    April 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Capital Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stent Stenosis, Intracranial Hypertension, Headache, Tinnitus, Papilledema, Visual Impairment
    Keywords
    Stenting, Jugular vein stenosis, Intracranial hypertension, Headache, Tinnitus, Papilledema, Visual impairment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Venous stenting (Group-1)
    Arm Type
    Experimental
    Arm Description
    Patients in this group will undergo venous stenting treatment at once after enrollment.
    Arm Title
    Stenting one-month after routine medical treatment (Group-2)
    Arm Type
    Experimental
    Arm Description
    Patients in this group will undergo routine medical treatment for one month, followed by venous stenting intervention.
    Intervention Type
    Procedure
    Intervention Name(s)
    Venous stenting for internal jugular vein stenosis
    Intervention Description
    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).
    Intervention Type
    Procedure
    Intervention Name(s)
    One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Correction of internal jugular vein stenosis (IJVS) and abnormal collateral veins
    Description
    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 Outcome Measure Information:
    Title
    The evaluation of cerebral spinal fluid (CSF) pressure
    Description
    CSF pressure will be assessed by lumbar puncture.
    Time Frame
    baseline, immediately post-stenting, within 1 month
    Title
    The evaluation of headache
    Description
    The intensity of headache will be assessed with the Headache Impact Test-6 (HIT-6).
    Time Frame
    baseline, within 1, 6 and 12 months
    Title
    The evaluation of tinnitus
    Description
    The severity of tinnitus will be assessed by the Tinnitus Handicap Inventory Questionnaire (THIQ).
    Time Frame
    baseline, within 1, 6 and 12 months
    Title
    The evaluation of the severity of papilledema and other ophthalmological conditions
    Description
    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
    Title
    Changes in cerebral white matter (WM)
    Description
    The characteristics of WM will be evaluated by Magnetic Resonance Imaging (MRI).
    Time Frame
    baseline, within 12 months
    Title
    The evaluation of cognitive function
    Description
    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).
    Time Frame
    baseline, within 12 months
    Title
    The evaluation of mental status
    Description
    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.
    Time Frame
    baseline, within 12 months
    Title
    The evaluation of sleeping status
    Description
    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.
    Time Frame
    baseline, within 12 months
    Title
    The extent of disability or dependence in the daily activities
    Description
    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.)
    Time Frame
    baseline, within 12 months
    Title
    Percentage of participants with abnormal lab values
    Description
    Lab examinations such as hepatic and renal function, blood and urine routine will be recorded.
    Time Frame
    baseline, within 12 months
    Title
    Percentage of participants with procedure-related and/or stenting-related complications
    Time Frame
    within 12 months
    Title
    The incidence of all cause mortality
    Description
    Death secondary to any reasons
    Time Frame
    within 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ran Meng, MD, PhD
    Phone
    +86-10-83198952
    Email
    Ranmeng2011@pku.org.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Da Zhou, MD, PhD Candidate
    Phone
    +86-10-83198952
    Email
    popdoctor@foxmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xuming Ji, MD, PhD
    Organizational Affiliation
    Xuanwu Hosptial, Capital Medical University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ran Meng, MD, PhD
    Organizational Affiliation
    Xuanwu Hosptial, Capital Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    29114973
    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.
    Results Reference
    background
    PubMed Identifier
    28321380
    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.
    Results Reference
    background
    PubMed Identifier
    24296639
    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.
    Results Reference
    background
    PubMed Identifier
    33281736
    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.
    Results Reference
    derived

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    Endovascular Stenting Treatment for Patients With Internal Jugular Vein Stenosis

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