Outcomes of Stent Placement in Adults with Idiopathic Intracranial Hypertension Patients and Venous Sinus Stenosis
B
Bradley N. Bohnstedt, MD
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
N/A
10 participants needed
2 Locations
Brief description of study
What is the purpose of this study?
Venous sinus stenosis has been identified as a potential etiology in Adults with Idiopathic Intracranial Hypertension (IIH). IIH can lead to significant disability including loss of vision, disabling headaches, and neurocognitive impairment. This study will analyze outcome data of stenting in adult patients with IIH and venous sinus stenosis.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Participants will be evaluated in clinic or in the emergency department. Determination of intervention will be made by primary surgeon in accordance to standard of care. Patients will be asked to participate in the study if they meet our inclusion criteria.
Detailed description of study
What will happen during the study?
- A baseline quality of life survey, which includes the IIH quality of life survey and HIT-6 survey, will be administered before operation.
- Duration of quality of life surveys will take approximately 10 minutes.
- During the procedure, patients will have two pressure recordings at the venous sinus stenosis. This will be done by using a fiberoptic wire and an arterial line attached to the catheter before and after stent placement.
- There is no additional risk, as the arterial line setup will be attached to the catheter and wire already being used for the stent placement.
- As part of routine clinical care, patients follow up in 1 month, 6months, and 1 year with their provider.
- During routine clinical follow up, we will administer another quality of life survey at 1 month, 6 months, and 1 year.
- Patients will additionally have blood drawn for analysis at the 6 month follow up appointment. This will be done for all patients that consent to be included in the trial and is not standard of care, unless otherwise indicated. These blood draws will be done by trained staff and take no more time than a standard blood draw for a CBC.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Idiopathic intracranial hypertension, Venous sinus stenosis
-
Age: 18 years - 100 years
-
Gender: All
Inclusion criteria:
- Patients diagnosed with IIH displaying symptoms refractory tomedication treatment
- Venous imaging shows venous sinus stenosis
Updated on
19 May 2025.
Study ID: SNEU-IIR-STENTPLACEMENT-IIH, 22536
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