Status:
UNKNOWN
Endovascular Stenting Treatment for Patients With Internal Jugular Vein Stenosis
Lead Sponsor:
Capital Medical University
Conditions:
Stent Stenosis
Intracranial Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03373292
Start Date
January 1 2018
End Date
April 1 2020
Last Update
December 14 2017
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