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Endovascular Stenting Treatment for Patients With Internal Jugular Vein Stenosis

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ClinicalTrials.gov Identifier: NCT03373292
Recruitment Status : 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

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).

Condition or disease Intervention/treatment Phase
Stent Stenosis Intracranial Hypertension Headache Tinnitus Papilledema Visual Impairment Procedure: Venous stenting for internal jugular vein stenosis Procedure: One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Feasibility, Safety and Efficacy of Venous Stenting for Internal Jugular Vein Stenosis
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Venous stenting (Group-1)
Patients in this group will undergo venous stenting treatment at once after enrollment.
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).


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.
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.





Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. Changes in cerebral white matter (WM) [ Time Frame: baseline, within 12 months ]
    The characteristics of WM will be evaluated by Magnetic Resonance Imaging (MRI).

  6. 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).

  7. 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.

  8. 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.

  9. 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.)

  10. 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.

  11. Percentage of participants with procedure-related and/or stenting-related complications [ Time Frame: within 12 months ]
  12. The incidence of all cause mortality [ Time Frame: within 12 months ]
    Death secondary to any reasons



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373292


Contacts
Contact: Ran Meng, MD, PhD +86-10-83198952 Ranmeng2011@pku.org.cn
Contact: Da Zhou, MD, PhD Candidate +86-10-83198952 popdoctor@foxmail.com

Sponsors and Collaborators
Capital Medical University
Investigators
Study Director: Xuming Ji, MD, PhD Xuanwu Hosptial, Capital Medical University
Principal Investigator: Ran Meng, MD, PhD Xuanwu Hosptial, Capital Medical University

Publications:
Responsible Party: Ji Xunming, Vice President, Professor, Xuanwu Hospital, Capital Medical University
ClinicalTrials.gov Identifier: NCT03373292     History of Changes
Other Study ID Numbers: Stenting2018-IJVS
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Ji Xunming, Capital Medical University:
Stenting
Jugular vein stenosis
Intracranial hypertension
Headache
Tinnitus
Papilledema
Visual impairment

Additional relevant MeSH terms:
Vision, Low
Hypertension
Constriction, Pathologic
Headache
Tinnitus
Vision Disorders
Intracranial Hypertension
Papilledema
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Eye Diseases
Brain Diseases
Central Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases