Intracranial Venous Stenting Evaluation in Patients With Idiopathic Intracranial Hypertension in the Early Phase

NCT ID: NCT06919744

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-19
• Study Completion Date: 2029-04-30

Brief Summary

This study is aimed at patients suffering from recently discovered intracranial hypertension, caracterized by visual loss, chronic headache and/or tinnitus. 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 car + stenting of the specific vein) and will undergo specific follow-up visits after 1, 3 and 12 months.

Detailed Description

The DIVE-IIN-EARLY trial is a multicenter randomized controlled trial designed to evaluate whether transverse venous sinus stenting is more effective than best medical therapy alone as first-line treatment for patients with idiopathic intracranial hypertension (IIH). The study targets patients with a new diagnosis of IIH with bilateral transverse sinus stenosis or unilateral stenosis of the dominant transverse sinus with a hypoplastic contralateral sinus.

Idiopathic intracranial hypertension is, in most cases, associated with narrowing of the transverse sinus vein, which may be the cause of increased intracranial blood pressure, resulting in the accumulation and increase in intracranial fluid pressure. This increased pressure is thought to be responsible for papilledema, chronic headaches, and tinnitus, among other symptoms.

Restoring a normal luminal diameter of the transverse sinus using a stent could therefore allow for the rapid restoration of normal intracranial pressures and an improvement in various symptoms.

Stent implantation in the transverse sinus is now part of standard care, but no large-scale clinical trial has formally established the superiority of the technique compared to the standard of care (drug therapy combined with weight gain). This study aims to provide evidence on the potential benefits of transverse venous sinus stenting as a treatment option for patients with idiopathic intracranial hypertension, which could significantly change the current management approach to this disease.

Usual medication for this condition is acetazolamide, but it's efficacy as well as it's tolerance is mostly poor. By proposing stenting in the early phase of the disease, one could avoid long term symptoms such as loss of vision and chronic headache.

Conditions

Idiopathic Intracranial Hypertension (IIH)

Study Design

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

Study Groups

best medical care

Acetazolamide and recommended weight loss

Group Type: ACTIVE_COMPARATOR

Best medical care

Intervention Type: DRUG

Acetazolamide will be introduced at the time of papilledema discovery. Weight loss will be recommended.

Experimental (stenting, neuro-radiological intervention)

Stenting of the tranverse sinus vein

Group Type: EXPERIMENTAL

Intervention (stenting)

Intervention Type: DEVICE

Transverse venous sinus will be stented by neuro-radiological intervention

Interventions

Best medical care

Acetazolamide will be introduced at the time of papilledema discovery. Weight loss will be recommended.

Intervention Type: DRUG

Intervention (stenting)

Transverse venous sinus will be stented by neuro-radiological intervention

Intervention Type: DEVICE

Other Intervention Names

Acetazolamide; Weight loss

Eligibility Criteria

Inclusion Criteria

1. Subject is ≥ 18 years old at inclusion.

2. Subject with definite new diagnosis (˂ 3 months) of IIH satisfying the modified Dandy criteria (A to E)

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

4. Normal MRI findings excepted intracranial TVS stenosis or IIH related abnormalities

5. Subject with ophthalmologic IIH symptoms and signs (RNFL ≥ 130 µm, Frisen score ≥ 2, and absence of differential diagnostic)

6. Subject without macular ganglion cells atrophy seen on OCT

7. Patient having received information about data collection and having signed and dated an Informed Consent Form

8. Subjects must be able to attend all scheduled visits and to comply with all trial procedures

9. Subjects must be covered by public health insurance

Exclusion Criteria

1. Subject previously treated with acetazolamide for IIH

2. Known contrast product, Nickel, titanium allergy

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

4. History of intracranial venous thrombosis or intracranial neoplasia

5. Fulminant decrease of visual acuity due to the IIH defined as a visual loss (of the most seriously impaired eye) of at least 3/10 (from corrected vision) within 4 weeks, in absence of any other ophthalmologic pathology and Mean Deficit of visual field superior to -10 dB

6. Macular ganglion cells atrophy seen on OCT

7. Optic nerve atrophy

8. Amblyopia

9. Refractive error greater ±8 sphere or more than ±3 in cylinder in either eye if there are abnormalities in funduscopy (optic disc tilt, staphyloma), previous glaucoma, other disorders causing visual loss

10. Pregnancy: if a woman is of childbearing potential a urine or serum beta HCG test is positive

11. Patient with a severe or fatal comorbidity that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.

12. Evidence of intracranial hemorrhage (subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), etc.)

13. Life expectancy under 6 months

14. Chronic IIH

15. Patients with renal failure (creatinine > 1.5 mg/dl and/or creatinine clearance < 60 mL/min, except if patient is already on hemodialysis)

16. History of previously implanted intra-cranial sinus stent

17. Previous gastric bypass surgery

18. Contra-indication to general anesthesia

19. Contra-indication to aspirin, clopidogrel or other P2Y12 anti-aggregant

20. History of chronic obstructive pulmonary disease or other severe respiratory disease

21. History of deep vein thrombosis or pulmonary embolism

22. History of atrial fibrillation or other risks of stroke

23. Cerebral vascular lesions (arteriovenous malformation, arteriovenous fistula, aneurysms, significant stenosis of extra- or intra-cranial vessels other than the targeted venous sinus stenosis, intracranial artery dissection, etc.).

24. Anatomical anomaly of the venous sinus which would prevent safe catheterization and stenting

25. Subject who are in a dependency or employment with the sponsor or the investigator

26. Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date

27. Subject protected according to the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship/curatorship)

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

Sponsors

Ministère de la Santé

UNKNOWN

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Montpellier Hôpital Gui de Chauliac

Montpellier, , France

Site Status: RECRUITING

CHU de REIMS

Reims, , France

Site Status: NOT_YET_RECRUITING

CHU de Toulouse

Toulouse, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Anne DUCROS, MD, PhD

Role: CONTACT

a-ducros@chu-montpellier.fr

+33 467 339 469

Fédérico CAGNAZZO, MD, PhD

Role: CONTACT

f-cagnazzo@chu-montpellier.fr

+33 467 337 532

Facility Contacts

Anne DUCROS, MD, PhD

Role: primary

a-ducros@chu-montpellier.fr

+33 467 339 469

Sébastien SOIZE, MD, PhD

Role: primary

ssoize@chu-reims.fr

+33 326 788 764

Guillaume BELLANGER, MD, PhD

Role: primary

bellanger.g@chu-toulouse.fr

+33 561 772 339

Other Identifiers

2024-A02444-43

Identifier Type: REGISTRY

Identifier Source: secondary_id

RECHMPL 23_0430

Identifier Type: -

Identifier Source: org_study_id