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Endovascular Stenting Treatment for Patients With Internal Jugular Vein Stenosis

NCT03373292 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-12-14

No results posted yet for this study

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Capital Medical University

    lead OTHER

Principal Investigators

  • Xuming Ji, MD, PhD · Xuanwu Hosptial, Capital Medical University

  • Ran Meng, MD, PhD · Xuanwu Hosptial, Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2020-01-31
Completion
2020-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03373292 on ClinicalTrials.gov