Skip to content

Safety and Efficacy of Endovascular Stenting for Idiopathic Intracranial Hypertension with Venous Sinus Stenosis

Safety and Efficacy of Endovascular Stenting for Idiopathic Intracranial Hypertension with Venous Sinus Stenosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-ONN-17010421
Enrollment
Unknown
Registered
2017-01-13
Start date
2014-01-01
Completion date
Unknown
Last updated
2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic intracranial hypertension with venous sinus stenosis

Interventions

Stenting:Intrasinus stenting
Medical therapy:use of acetazolamide, weight loss with a low calorie diet, and taking analgesics for headache

Sponsors

Department of Interventional Neuroradiology, Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 18-80 years 2. Headache, impaired vision, papilledema or tinnitus 3. Normal brain parenchyma without hydrocephalus, mass or structural lesion, and no abnormal meningeal enhancement on CT or MRI 4. Normal CSF composition 5. CSF opening pressure > 25 cmH2O or pressure of 20 to 25 cmH2O and at least one of the following: (1) pulsatile tinnitus, (2) abducens nerve palsy, (3) papilledema of = grade 2, (4) MRV with lateral sinus collapse/stenosis, (5) partially empty sella on coronal or sagittal views and optic nerve sheaths with filled out CSF spaces next to the globe on T2 weighted axial scans 6. Localized VSS with stenosis degree = 50% on DSA 7. Pressure gradient across the stenotic segment = 8 mmHg

Exclusion criteria

Exclusion criteria: 1. DSA showed diffused venous sinus stenosis, cortical or deep vein stenosis 2. A history of severe thyroid disease and iodine allergy 3. Pregnant or lactating women 4. Severe cardiopulmonary, liver or kidney failure 5. Known hereditary or acquired haemorrhagic diathesis 6. Known hereditary or acquired thrombophilia 7. Platelet counts or coagulation abnormality 8. Major surgery or severe trauma or any traumatic brain injury within the previous 14 days 9. A history of cerebral hemorrhage, arteriovenous malformation, intracranial aneurysm or tumor 10. Other life threatening illness (eg, advanced cancer) likely to lead to death within a few months

Design outcomes

Primary

MeasureTime frame
The proportion of symptom-free and improved;The proportion of symptom-free and improved;The proportion of symptom-free and improved;The proportion of symptom-free and improved;

Secondary

MeasureTime frame
Post-procedural pressure gradient across the stenosis (assessed only in the stenting group);CSF opening pressure after treatment;

Countries

China

Contacts

Public ContactDapeng Mo

Department of Interventional Neuroradiology, Beijing Tiantan Hospital, Capital Medical University

modapeng1971@163.com+86 18811039300

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 21, 2026