Back to resultsEndovascular 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
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
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.
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
NCT ID
NCT03373292
First Posted
December 3, 2017
Last Updated
December 8, 2017
Sponsor
Capital Medical University
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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