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Stent StenosisPhase 1NCT03373292

Endovascular Stenting Treatment for Patients With Internal Jugular Vein Stenosis

A Phase 1 study testing Venous stenting for internal jugular vein stenosis and One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis in people with Stent Stenosis and Intracranial Hypertension, run by Capital Medical University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Venous stenting for internal jugular vein stenosis and One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Jan 2018to Apr 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet.

Ran Meng, MD, PhD contact

+86-10-83198952

Ranmeng2011@pku.org.cn

Da Zhou, MD, PhD Candidate contact

+86-10-83198952

popdoctor@foxmail.com

About this study

Official title: Evaluation of the Feasibility, Safety and Efficacy of Venous Stenting for Internal Jugular Vein Stenosis

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).

Read the 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.

Being tested
Venous stenting for internal jugular vein stenosis, One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis
Keywords
Stenting, Jugular vein stenosis, Intracranial hypertension, Headache, Tinnitus, Papilledema, Visual impairment
Medical subject headings
Intracranial Hypertension, Headache, Tinnitus, Papilledema, Vision Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Venous stenting for internal jugular vein stenosisProcedure or surgery

    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).

  • One-month routine medical treatment followed by venous stenting for internal jugular vein stenosisProcedure or surgery

    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 groups in NCT03373292
Study groupRoleWhat they receive
Venous stenting (Group-1)ExperimentalPatients in this group will undergo venous stenting treatment at once after enrollment.
Receives: Procedure: Venous stenting for internal jugular vein stenosis
Stenting one-month after routine medical treatment (Group-2)ExperimentalPatients in this group will undergo routine medical treatment for one month, followed by venous stenting intervention.
Receives: Procedure: One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: baseline, 1, 6 and 12 months

Secondary outcomes (12)

  1. The evaluation of cerebral spinal fluid (CSF) pressure

    CSF pressure will be assessed by lumbar puncture.

    Measured: baseline, immediately post-stenting, within 1 month

  2. The evaluation of headache

    The intensity of headache will be assessed with the Headache Impact Test-6 (HIT-6).

    Measured: baseline, within 1, 6 and 12 months

  3. The evaluation of tinnitus

    The severity of tinnitus will be assessed by the Tinnitus Handicap Inventory Questionnaire (THIQ).

    Measured: baseline, within 1, 6 and 12 months

  4. 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.

    Measured: baseline, within 1, 6 and 12 months

  5. Changes in cerebral white matter (WM)

    The characteristics of WM will be evaluated by Magnetic Resonance Imaging (MRI).

    Measured: baseline, within 12 months

  6. 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).

    Measured: baseline, within 12 months

  7. 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.

    Measured: baseline, within 12 months

  8. 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.

    Measured: baseline, within 12 months

  9. 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.)

    Measured: baseline, within 12 months

  10. Percentage of participants with abnormal lab values

    Lab examinations such as hepatic and renal function, blood and urine routine will be recorded.

    Measured: baseline, within 12 months

  11. Percentage of participants with procedure-related and/or stenting-related complications

    Measured: within 12 months

  12. The incidence of all cause mortality

    Death secondary to any reasons

    Measured: within 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2017
  2. Study startJan 2018 (estimated)
  3. Primary completionJan 2020 (estimated)
  4. Study completionApr 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03373292
Sponsor's protocol ID
Stenting2018-IJVS
Status last verified
Dec 2017
First submitted
3 Dec 2017
Last updated
14 Dec 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29114973

  • 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.

    PubMed 28321380

  • 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.

    PubMed 24296639

  • 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.

    PubMed 33281736

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Venous stenting for internal jugular vein stenosis and One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis in people with Stent Stenosis and Intracranial Hypertension, run by Capital Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ran Meng, MD, PhD (+86-10-83198952, Ranmeng2011@pku.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correction of internal jugular vein stenosis (IJVS) and abnormal collateral veins (time frame: baseline, 1, 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03373292, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017.

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