Endovascular Stenting Treatment for Patients With Internal Jugular Vein Stenosis

NCT ID: NCT03373292

Last Updated: 2017-12-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2020-04-30

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 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

Keywords

Stenting; Jugular vein stenosis; Intracranial hypertension; Headache; Tinnitus; Papilledema; Visual impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Venous stenting (Group-1)

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

Group Type: EXPERIMENTAL

Venous stenting for internal jugular vein stenosis

Intervention Type: PROCEDURE

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).

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming

Vice President, Professor, Xuanwu Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xuming Ji, MD, PhD

Role: STUDY_DIRECTOR

Xuanwu Hosptial, Capital Medical University

Ran Meng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hosptial, Capital Medical University

Central Contacts

Ran Meng, MD, PhD

Role: CONTACT

Phone: +86-10-83198952

Email: Ranmeng2011@pku.org.cn

Da Zhou, MD, PhD Candidate

Role: CONTACT

Phone: +86-10-83198952

Email: popdoctor@foxmail.com

References

Zhou D, Meng R, Zhang X, Guo L, Li S, Wu W, Duan J, Song H, Ding Y, Ji X. Intracranial hypertension induced by internal jugular vein stenosis can be resolved by stenting. Eur J Neurol. 2018 Feb;25(2):365-e13. doi: 10.1111/ene.13512. Epub 2017 Dec 7.

Reference Type: BACKGROUND

PMID: 29114973 (View on PubMed)

Higgins JN, Garnett MR, Pickard JD, Axon PR. An Evaluation of Styloidectomy as an Adjunct or Alternative to Jugular Stenting in Idiopathic Intracranial Hypertension and Disturbances of Cranial Venous Outflow. J Neurol Surg B Skull Base. 2017 Apr;78(2):158-163. doi: 10.1055/s-0036-1594238. Epub 2016 Nov 23.

Reference Type: BACKGROUND

PMID: 28321380 (View on PubMed)

Spitze A, Malik A, Lee AG. Surgical and endovascular interventions in idiopathic intracranial hypertension. Curr Opin Neurol. 2014 Feb;27(1):69-74. doi: 10.1097/WCO.0000000000000049.

Reference Type: BACKGROUND

PMID: 24296639 (View on PubMed)

Ding J, Liu Y, Li X, Chen Z, Guan J, Jin K, Wang Z, Ding Y, Ji X, Meng R. Normobaric Oxygen May Ameliorate Cerebral Venous Outflow Disturbance-Related Neurological Symptoms. Front Neurol. 2020 Nov 13;11:599985. doi: 10.3389/fneur.2020.599985. eCollection 2020.

Reference Type: DERIVED

PMID: 33281736 (View on PubMed)

Other Identifiers

Stenting2018-IJVS

Identifier Type: -

Identifier Source: org_study_id