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Search / Trial NCT05050864

Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.

Launched by FONDATION OPHTALMOLOGIQUE ADOLPHE DE ROTHSCHILD · Sep 10, 2021

Trial Information

Current as of November 11, 2025

Recruiting

Keywords

Endovacascular Ventricular Shunt Papillary Edema Visual Field

ClinConnect Summary

This clinical trial is studying two different treatment options for a condition called idiopathic intracranial hypertension (HTICi), which often affects young women. This condition involves an increase in pressure inside the head, which can lead to swelling of the optic nerve and potentially cause vision problems or blindness. The trial aims to compare the effectiveness and safety of two surgical approaches: a procedure that creates a bypass for cerebrospinal fluid and another that involves placing a stent in the veins of the brain. These treatments are considered when the first-line medication isn’t working well enough.

To participate in this trial, you must be at least 18 years old and have been diagnosed with HTICi, showing specific signs of increased pressure. You should also have experienced problems with your vision due to this condition and have not found relief from medication. Participants can expect to receive one of the two treatments and will be monitored closely to see which option works better for improving their vision and overall safety. It's important to know that this trial is currently recruiting participants, and there are certain health conditions that may prevent someone from joining.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patient aged 18 or over
  • HTICi proven greater than 25cm of water
  • Presence of papillary edema (grade\> 0 on the Frisen scale)
  • Stenosis of at least one transverse sinus on MRI
  • Failure of medical treatment and surgical / interventional indication defined by the medical team taking care of the patient
  • Consent to participate in the study
  • Exclusion Criteria:
  • Fulminant HTICi
  • Contraindication to antiplatelet aggregation
  • Contraindication to one or the other of the interventions under study
  • Pregnant or breastfeeding woman

About Fondation Ophtalmologique Adolphe De Rothschild

The Fondation Ophtalmologique Adolphe de Rothschild is a leading French institution dedicated to advancing ophthalmic research and patient care. Renowned for its commitment to innovation in eye health, the foundation conducts cutting-edge clinical trials aimed at improving treatments for various ocular conditions. With a multidisciplinary team of experts, the foundation collaborates with academic and industry partners to enhance understanding of eye diseases and develop novel therapeutic solutions, ultimately striving to improve patient outcomes and quality of life in ophthalmology.

Locations

Paris, France

Paris, France

Patients applied

0 patients applied

Trial Officials

Pierre Bourdillon, MD

Principal Investigator

Fondation A. de Rothschild

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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