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Endovascular Stenting Treatment for Patients With Internal Jugular Vein Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03373292
Recruitment Status : Unknown
Verified December 2017 by Ji Xunming, Capital Medical University.
Recruitment status was:  Not yet recruiting
First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Ji Xunming, Capital Medical University

Tracking Information
First Submitted Date  ICMJE December 3, 2017
First Posted Date  ICMJE December 14, 2017
Last Update Posted Date December 14, 2017
Estimated Study Start Date  ICMJE January 2018
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
Correction of internal jugular vein stenosis (IJVS) and abnormal collateral veins [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
  • The evaluation of cerebral spinal fluid (CSF) pressure [ Time Frame: baseline, immediately post-stenting, within 1 month ]
    CSF pressure will be assessed by lumbar puncture.
  • The evaluation of headache [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
  • Changes in cerebral white matter (WM) [ Time Frame: baseline, within 12 months ]
    The characteristics of WM will be evaluated by Magnetic Resonance Imaging (MRI).
  • The evaluation of cognitive function [ Time Frame: 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).
  • The evaluation of mental status [ Time Frame: 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 sleeping status [ Time Frame: 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 extent of disability or dependence in the daily activities [ Time Frame: 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 [ Time Frame: baseline, within 12 months ]
    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 [ Time Frame: within 12 months ]
  • The incidence of all cause mortality [ Time Frame: within 12 months ]
    Death secondary to any reasons
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endovascular Stenting Treatment for Patients With Internal Jugular Vein Stenosis
Official Title  ICMJE Evaluation of the Feasibility, Safety and Efficacy of Venous Stenting for Internal Jugular Vein Stenosis
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stent Stenosis
  • Intracranial Hypertension
  • Headache
  • Tinnitus
  • Papilledema
  • Visual Impairment
Intervention  ICMJE
  • Procedure: Venous stenting for internal jugular vein stenosis

    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).

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

    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.

Study Arms  ICMJE
  • Experimental: Venous stenting (Group-1)
    Patients in this group will undergo venous stenting treatment at once after enrollment.
    Intervention: Procedure: Venous stenting for internal jugular vein stenosis
  • Experimental: Stenting one-month after routine medical treatment (Group-2)
    Patients in this group will undergo routine medical treatment for one month, followed by venous stenting intervention.
    Intervention: Procedure: One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 8, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03373292
Other Study ID Numbers  ICMJE Stenting2018-IJVS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ji Xunming, Capital Medical University
Study Sponsor  ICMJE Capital Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Xuming Ji, MD, PhD Xuanwu Hosptial, Capital Medical University
Principal Investigator: Ran Meng, MD, PhD Xuanwu Hosptial, Capital Medical University
PRS Account Capital Medical University
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP