Endovascular Stenting Treatment for Patients With Internal Jugular Vein Stenosis

Capital Medical University

Status and phase: Unknown; Phase 1

Conditions: Papilledema; Stent Stenosis; Tinnitus; Visual Impairment; Intracranial Hypertension; Headache

Treatments: Procedure: Venous stenting for internal jugular vein stenosis; Procedure: One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis

Study type: Interventional

Funder types: Other

Identifiers

NCT03373292

Stenting2018-IJVS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ranging from 18 to 80 years of age, both genders.
2. Patients diagnosed with IJVS surrounded by abnormally and tortuous collateral veins verified by MRV, CTV and/or DSA.
3. Pressure gradient across the stenotic segments is equal to or greater than 4 mmHg.
4. Intracranial hypertension associated manifestations cannot be satisfactorily controlled by conservative or non-surgical therapies.
5. Informed consent obtained from the patient or his/her health care proxy, able to cooperate follow-up visits.

Exclusion criteria

1. External osseous impingement associated IJVS.
2. Contraindication to iodinated contrasts.
3. Contraindication to general anesthesia.
4. Contraindication to standard medical therapy such as Aspirin, Clopidogrel or anticoagulants.
5. Intracranial abnormalities such as tumor, abscess, vascular malformation, cerebral venous sinus stenosis or thrombosis.
6. Previous history of major surgeries within 30 days prior to inclusion, or scheduled for any of the procedures within 12 months after inclusion.
7. Severe hematological, hepatic or renal dysfunctions.
8. Current or having a history of chronic physical diseases or mental disorders.
9. Pregnant or lactating women.
10. Life expectancy < 1 year due to concomitant life-threatening illness.
11. Patients unlikely to be compliant with intervention or return for follow-up visits.
12. No signed consent from the patient or available legally authorized representatives.
13. Patients recruited to other clinical trials with medications or devices, which may affect the outcome of this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Venous stenting (Group-1)

Experimental group

Description:

Patients in this group will undergo venous stenting treatment at once after enrollment.

Treatment:

Procedure: Venous stenting for internal jugular vein stenosis

Stenting one-month after routine medical treatment (Group-2)

Experimental group

Description:

Patients in this group will undergo routine medical treatment for one month, followed by venous stenting intervention.

Treatment:

Procedure: One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis