Symptomatic Incracranial venous sinus stenosis
Conditions
Interventions
single arm:Endovascular Treatment: Intracranial Stenting
Sponsors
The General Hospital of People's Liberation Army (The 301st Hospital)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years. 2. The stenosis of at least one side of the lateral sinus (lateral sinus to sigmoid sinus) which confirmed by whole cerebral angiography and met one of the following criteria: 1) The pressure gradient at both ends of the stenosis was >= 10 mm Hg (1 mm Hg = 0.133 kPa) and complicated with intracranial hypertension and experiencing headache and optic papillary edema, or the presence of intracranial hypertension confirmed by lumbar puncture (lumbar puncture pressure>250mmH2O). 2) The pressure gradient at both ends of the stenosis was < 10 mm Hg (1 mm Hg = 0.133 kPa) but with pulsatile tinnitus on the stenotic side. 3. The patient or the legal representative is willing to cooperate with intracranial venous sinus stenting and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Standardized treatment of acute cerebral venous sinus thrombosis 3 times normal value upper limit or AST > 3 times normal value upper limit, creatinine > 1.5 times normal value upper limit). 6. Pregnant. 7. Expected survival less than 1 year. 8. Previous intracranial hemorrhage, including cerebral parenchyma hemorrhage, subarachnoid hemorrhage and epidural hemorrhage. 9. Untreated intracranial aneurysms and vascular malformations. 10. Vascular pathway unsuitable for interventional therapy. 11. Cognitive impairment, mental illness, no cooperation. 12. In other clinical trials in recent 3 months. 13. The researchers believe that patients are not suitable for endovascular treatment of intracranial venous sinus stents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immediate success rate of endovascular treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target in-segment DS% (imaging end point) at 12 months after procedure;Recurrence rate of related symptoms and incidence of other serious adverse events 30 days after procedure;Recurrence rate of related symptoms and incidence of other serious adverse events 6 months after procedure;Recurrence rate of related symptoms and incidence of other serious adverse events 9 months after procedure;Recurrence rate of related symptoms and incidence of other serious adverse events 12 months after procedure;Pre-procedural/ post in-segment pressure difference (mmHg or mmH2O);CT or MRI indicator;Lumbar puncture pressure difference; | — |
Countries
China
Contacts
Public ContactJun Wang
The General Hospital of People's Liberation Army (The 301st Hospital)
Outcome results
None listed