NCT03373292

Endovascular Stenting Treatment for Patients With Internal Jugular Vein Stenosis

Evaluation of the Feasibility, Safety and Efficacy of Venous Stenting for Internal Jugular Vein Stenosis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Stent Stenosis
• Intracranial Hypertension
• Headache
• Tinnitus
• Papilledema
• Visual Impairment

Interventions

Type	Name	Description
PROCEDURE	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).
PROCEDURE	One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis	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.

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-01-01
• Completion: 2020-04-01
• First posted: 2017-12-14
• Last updated: 2017-12-14