Stenting of venous sinus stenosis for medically refractory idiopathic intracranial hypertension

• Register: ISRCTN
• Last refreshed on: 5 January 2021
• Main ID: ISRCTN13784335
• Date of registration: 13/08/2015
• Prospective Registration: No
• Primary sponsor: CHU de Québec
• Public title: Stenting of venous sinus stenosis for medically refractory idiopathic intracranial hypertension
• Scientific title: Stenting of venous sinus stenosis for medically refractory idiopathic intracranial hypertension: a cohort study
• Date of first enrolment: 20/09/2011
• Target sample size: 33
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN13784335
• Study type: Interventional
• Study design: Cohort study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Canada

Contacts

• Name: Pascale Lavoie

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic intracranial hypertension
Nervous System Diseases
Benign intracranial hypertension

Intervention(s)

Endovascular venous sinus stenting.

Primary Outcome(s)

CSF pressure normalisation at 6 months follow up. CSF pressure will be measured by lumbar puncture at the start of the trial and 6 months after the stenting. A normalisation is defined as at least a 15 mmHg difference between pre- and post-op lumbar puncture.

Secondary Outcome(s)

1. Significant decrease in CSF pressure at 6 months
2. Improvement of visual fields, visual acuity, vision color, visual evoked potential at 3 months and 12 months
3. Improvement of papilloedema (according to Frisén scale) at 3 months and absence of papilloedema at 12 months, with improvement of OCT
4. Resolution of visual complaints (transient visual losses, visual obscurations, poor vision, blurring of vision etc.) at 12 months
5. Decrease of headaches score (HIT-6) and severity at 12 months
6. Improvement in Quality of Life at 12 months
7. 12 months stent patency on CT-Venous angiogram
8. Safety and treatment side effects immediately after intervention and at 1 month (evaluated in neurology), and modified Rankin scale immediately after intervention and at 1 month.

Secondary ID(s)

2012-1482

Source(s) of Monetary Support

Canadian Heads of Academic Radiology/GE Healthcare Development Program (Canada), Laval University - Department of Medical Imaging (Université Laval) (Canada)

Ethics review

Status:
Approval date:
Contact:

Ethics Committee of Hospital Center University of Quebec (Centre Hospitalier Universitaire (CHU) de Québec), 12/01/2011, ref: 2012-1482, PEJ-578.

Results

• Results available: Yes
• Date Completed: 05/01/2015