A Phase 1 interventional study of Venous stenting for internal jugular vein stenosis and One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis in Stent Stenosis, Intracranial Hypertension and Headache, sponsored by Capital Medical University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-14.
Sponsored by Capital Medical University · Phase 1, Interventional, and Treatment
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).
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.
165 studies on the registry are indexed under Intracranial Hypertension; 36 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 81 interventional studies indexed under Intracranial Hypertension.
Browse Intracranial Hypertension studies →Capital Medical University is the lead sponsor of 295 studies on the registry; 91 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this group will undergo venous stenting treatment at once after enrollment.
Procedure: Venous stenting for internal jugular vein stenosis
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
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).
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.
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).
Time frame: baseline, 1, 6 and 12 months
The evaluation of cerebral spinal fluid (CSF) pressure
CSF pressure will be assessed by lumbar puncture.
Time frame: baseline, immediately post-stenting, within 1 month
The evaluation of headache
The intensity of headache will be assessed with the Headache Impact Test-6 (HIT-6).
Time frame: baseline, within 1, 6 and 12 months
The evaluation of tinnitus
The severity of tinnitus will be assessed by the Tinnitus Handicap Inventory Questionnaire (THIQ).
Time frame: baseline, within 1, 6 and 12 months
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.
Time frame: baseline, within 1, 6 and 12 months
Changes in cerebral white matter (WM)
The characteristics of WM will be evaluated by Magnetic Resonance Imaging (MRI).
Time frame: baseline, within 12 months
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).
Time frame: baseline, within 12 months
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.
Time frame: baseline, within 12 months
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.
Time frame: baseline, within 12 months
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.)
Time frame: baseline, within 12 months
Percentage of participants with abnormal lab values
Lab examinations such as hepatic and renal function, blood and urine routine will be recorded.
Time frame: baseline, within 12 months
Percentage of participants with procedure-related and/or stenting-related complications
Time frame: within 12 months
The incidence of all cause mortality
Death secondary to any reasons
Time frame: within 12 months
No study locations are listed for this record.
Plan to share: Undecided
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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