CompletedPhase 1

Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy

United States20 participantsStarted 2012-01

Plain-language summary

Idiopathic Intracranial Hypertension (IIH) is a disease that affects mainly young people, and is associated with headache and loss of vision. The medical and surgical management of IIH is problematic and many patients are not treated effectively. Some cases of IIH are associated with severe stenosis of the large veins of the brain and various researchers have recently reported significant improvement in patients with IIH after the narrow veins of the brain were treated with a stent. Our project aims to evaluate the safety and long-term efficacy of venous sinus stenting in patients with severe IIH refractory to medical management.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age \> 18 years
✓. Established diagnosis of Idiopathic Intracranial Hypertension according to the criteria of the 2004 International Classification of Headache Disorders (Table 3).
✓. Visual field loss: One of criteria A, B or C must be fulfilled.
✓. Magnetic Resonance Venography (MRV) or Computed Tomography Venography (CTV) demonstrating bilateral transverse sinus stenosis or unilateral transverse sinus stenosis with contralateral transverse sinus hypoplasia or atresia. At least one of the stenoses must cause ≥ 50% reduction of the sinus lumen diameter.
✓. Signed informed consent obtained from the patient.

What they're measuring

Absence of procedure related and device related complications.

Timeframe: 24 months

Clinically significant cerebrospinal fluid (CSF) pressure reduction AND improvement of more than one grade in the Humphrey Field SITA Standard 24-2 Test grading scale.

Timeframe: 24 months

Greater than 2 decibel (dB) mean deviation compared to the pre-operative field testing.

Timeframe: 24 months

Trial details

NCT IDNCT01407809

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-01

View on ClinicalTrials.gov More Idiopathic Intracranial Hypertension (IIH) trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age \> 18 years
✓. Established diagnosis of Idiopathic Intracranial Hypertension according to the criteria of the 2004 International Classification of Headache Disorders (Table 3).
✓. Visual field loss: One of criteria A, B or C must be fulfilled.
✓. Magnetic Resonance Venography (MRV) or Computed Tomography Venography (CTV) demonstrating bilateral transverse sinus stenosis or unilateral transverse sinus stenosis with contralateral transverse sinus hypoplasia or atresia. At least one of the stenoses must cause ≥ 50% reduction of the sinus lumen diameter.
✓. Signed informed consent obtained from the patient.

What they're measuring

Absence of procedure related and device related complications.

Timeframe: 24 months

Clinically significant cerebrospinal fluid (CSF) pressure reduction AND improvement of more than one grade in the Humphrey Field SITA Standard 24-2 Test grading scale.

Timeframe: 24 months

Greater than 2 decibel (dB) mean deviation compared to the pre-operative field testing.

Timeframe: 24 months