Stenting of venous sinus stenosis for medically refractory idiopathic intracranial hypertensio

Not Applicable

Completed

• Conditions: Idiopathic intracranial hypertension; Nervous System Diseases; Benign intracranial hypertension

• Registration Number: ISRCTN13784335
• Lead Sponsor: CHU de Québec

Brief Summary

2018 adverse event report in https://pubmed.ncbi.nlm.nih.gov/28992723/ (added 17/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-01-05
• Study Start: 2015-08-13
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Patients aged 18 and over with diagnosis of IIH according to Friedman diagnostic criteria for whom standard medical treatment has failed (defined as persistent headaches or visual symptoms or papilloedema in spite of 3 months treatment with Diamox or intolerance of side effect of the medication)
2.Venous imaging (CT, MR or standard venography) showing bilateral transverse sinus stenoses or unilateral transverse sinus stenosis with contralateral transverse sinus atresia. At least one of the stenosis must cause >50% reduction of the sinus lumen.
3. Pressure gradient across the stenosis >8 mmHg
4. Signed informed consent obtained from the patient

Exclusion Criteria

1. Allergic reaction to iodine contrast despite premedication
2. Contraindication to general anaesthesia
3. Contraindication to aspirin, Clopidogrel (Plavix®) or anticoagulants
4. Patient with medical history of intracranial venous thrombosis (which do not correspond to idiopathic intracranial hypertension and increase risk of venous stent thrombosis)
5. Pregnant women

Study & Design

• Study Type: Interventional
• Study Design: Not specified