Condition category
Nervous System Diseases
Date applied
01/05/2015
Date assigned
13/08/2015
Last edited
13/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Intracranial hypertension (IH) describes abnormally high pressure inside the skull. Symptoms of IH include severe throbbing headaches that are worse in the morning and changes in vision. There are various recognised causes of IH, such as a brain tumour or brain infection. Sometimes there is no obvious cause of IH, and in these instances it is described as idiopathic intracranial hypertension (IIH). Severe narrowing (stenosis) of the vein (transverse-sigmoid) sinuses on both sides of the head has been recognised as a potential cause of IIH. One way to treat narrow vein sinuses in IIH is to surgically insert stents into them. A stent is a small mesh tube that is often used to widen narrow blood vessels, such as arteries. Stenting in IIH may help normalise the pressure of cerebrospinal fluid (CSF), the liquid which fills and surrounds the brain. Normalisation of CSF may help reduce the visual symptoms and headaches associated with IIH in patients. The aim of this study is to see how effective and safe venous sinus stenting is in patients that have not responded to other types of treatment for IIH.

Who can participate?
Adults diagnosed with IIH.

What does the study involve?
All participants have venous sinus stenting surgery. Participants complete questionnaires and attend follow up 1 month after treatment, then again at 3, 6 and 12 months.

What are the possible benefits and risks of participating?
Research studies such as this are performed to determine how safe and effective a specific medical treatment or device is. No direct benefit to participants can be guaranteed. The risks associated with the stent procedure (including those associated with the cerebral angiogram) include transient neurological deficit, permanent neurological deficit (or stroke), hearing loss, unsteadiness, cerebral bleeding, death, contrast material (X-ray dye) or drug allergic reaction, kidney failure, infection, cerebral venous stroke or blockage to the artery in the leg requiring surgical repair or the need for blood transfusion. All risks will be fully discussed with participants.

Where is the study run from?
Hospital Center University of Quebec - Hospital of the Child Jesus (CHU de Québec - Hôpital de l'Enfant-Jésus) (Canada)

When is the study starting and how long is it expected to run for?
September 2010 to January 2015

Who is funding the study?
1. Canadian Heads of Academic Radiology/GE Healthcare Development Program (Canada)
2. Laval University - Department of Medical Imaging (Université Laval) (Canada)

Who is the main contact?
Dr P Lavoie

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pascale Lavoie

ORCID ID

Contact details

Hôpital de l'Enfant-Jésus
Département des Sciences neurologiques
1401 18e rue
Québec (QC)
G1J 1Z4
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2012-1482

Study information

Scientific title

Stenting of venous sinus stenosis for medically refractory idiopathic intracranial hypertension: a cohort study

Acronym

Study hypothesis

Severe bilateral stenosis of the transverse-sigmoid sinuses has been recognised as a potential etiology of idiopathic intracranial hypertension (IIH). The treatment and prevention of these stenosis by venous sinus stenting may be effective in normalising the cerebrospinal fluid (CSF) pressure, reducing visual symptoms and headaches in patients with IIH refractory to other treatment.

Ethics approval

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

Study design

Cohort study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Idiopathic intracranial hypertension

Intervention

Endovascular venous sinus stenting.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/09/2010

Overall trial end date

05/01/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

33

Participant 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

Recruitment start date

20/09/2011

Recruitment end date

12/03/2014

Locations

Countries of recruitment

Canada

Trial participating centre

Hospital Center University of Quebec - Hospital of the Child Jesus (CHU de Québec - Hôpital de l'Enfant-Jésus)
1401 18E street
Québec
G1J 1Z4
Canada

Sponsor information

Organisation

CHU de Québec

Sponsor details

1401 18E rue
Québec (QC)
G1J 1Z4
Canada

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Canadian Heads of Academic Radiology/GE Healthcare Development Program (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Laval University - Department of Medical Imaging (Université Laval) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

An article will be submitted to Stroke journal and the results will be presented at a national conference such as The Canadian Society for Neurological Sciences.

Intention to publish date

01/06/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes