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Venous Stenting Evaluation in Patients With Intracranial Hypertension Under Long-term Acetazolamide

ConditionIdiopathic Intracranial Hypertension (IIH)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

This study is aimed at patients suffering from long term intracranial hypertension (caracterized by visual loss, chronic headache and/or tinnitus), receiving acetazolamide for more than 1 year, having inadequate response to treatment (untolerable side effects or insufficient efficacy).

The goal is to evaluate if stenting of a specific vein in the brain could decrease the hypertension and improve associated symptoms. Patients will be randomly assigned in either best medical care group (recommended medication associated with weight loss) or interventional group (best medical care + stenting of the specific vein) and will undergo specific follow-up visits after 1, 3 and 12 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject is ≥ 18 years old at inclusion.

Subject with definite diagnosis of IIH satisfying the modified Dandy criteria (A to E) ) at the time of initial diagnosis, under BMM including ACZ for more than 1 year

Patient with elevated intracranial pressure defined as > 25 cm H20 or 18 mmHg

Subject with intracranial TVS stenosis on dominant transverse sinus and hypoplastic contralateral one (or bilateral TVS stenosis) diagnosed on MRI

Disqualifiers

Patients receiving topiramate in the previous month

Known contrast product, Nickel, titanium allergy

Exposure to an oral drug (other than ACZ), substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis (lithium, vitamin A, tetracycline and related compounds)

History of intracranial venous thrombosis or intracranial neoplasia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acetazolamide

    Drug

    Acetazolamide will be maintained and weight loss will be recommended

  • Stent (Tentos 4F or Precise ProRX)

    Device

    Transverse venous sinus will be stented by neuroradiological intervention

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: AcetazolamideActive comparator 1 intervention
Group B: Experimental (stenting, neuro-radiological intervention)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of patients with normalization of intra-cranial pressure

Rate of patients with normalization of intra-cranial pressure (defined as ≤ 25 cm H20 or 18 mmHg)

Time frame
3 months

Secondary outcomes

1

Discontinuation of Acetazolamide

Percentage of patients discontinuing ACZ in the stenting group without papillary edema recurrence

Time frame
1 month
2

Discontinuation of Acetazolamide

Percentage of patients discontinuing ACZ in the stenting group without papillary edema recurrence

Time frame
3 months
3

Headache

Change in mean HIT-6 grading scale score (patient's questionnaire containing 6 questions to evaluate the severity of headache)

Time frame
3 and 12 months
4

Monthly headache days

Change in monthly headache days (within the last month) reported on patients' dairy

Time frame
3 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Direction Générale de l'Offre de Soins

Collaborator

Source ClinicalTrials.gov
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