Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)

ConditionsIdiopathic Intracranial Hypotension Venous Sinus Stenosis

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-60

SponsorBeijing Tiantan Hospital

About this trial

The aim of this study is to assess the efficacy of stent implantation versus medical therapy on idiopathic intracranial hypertension with venous sinus stenosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject Eligibility Criteria

Diagnosis of IIH by modified Dandy criteria about for more than 2 months

Lumbar puncture opening pressure ≥250 mmH₂O within 6 weeks before enrollment

Normal cerebrospinal fluid (CSF) composition

Disqualifiers

Subject Exclusion Criteria

Previous surgery for IIH, including optic nerve sheath fenestration (ONSF), CSF shunting, decompressive craniectomy or venous sinus stenting

Progressive or rapid visual loss needed urgent surgical intervention; if delay>24-48 h consider interim lumbar drain (for rapid visual loss only).Surgical options to consider: CSF diversion or optic nerve sheath fenestration

Visual loss due to other etiologies (eg, retinal drusen, retinal and optic neuropathy, cataracts, etc)

Trial design

Design model

Parallel

Treatments tested in this trial

Stent Implantation
Procedure/Surgery
Aspirin (100 mg) and clopidogrel (75 mg) were administered 3-5 days before endovascular treatment. The endovascular procedure was performed under general anesthesia. Intravenous heparin was administered during the stent procedure to increase the activated clotting time to \> 250 s. An 8F guiding catheter was delivered to the internal jugular vein near the skull base. A 6F Navien intermediate guide catheter was then placed into the distal transverse sinus near the torcula through the 8F guiding catheter. A microguidewire was navigated across the stenosis using a microcatheter, followed by the deployment of a self-expanding stent (eg, Precise or Wallstent) adjusted to the normal sinus venous diameter adjacent to the stenosis. Venography and manometry were performed after the procedure. Postoperatively, all patients received dual antiplatelet medications for 3 months and then received a single antiplatelet (either aspirin or clopidogrel).
Acetazolamide-based medical therapy
Drug
The medical treatment consisted of acetazolamide (0.5-4 g/day) and short-term mannitol (bolus of 0.25-1 g/kg body weight) for a duration of about 1 week or repeated lumbar punctures to reduce intracranial pressure (20 mL each), as well as analgesics for headaches. The initial dosage of acetazolamide was 0.5 g daily in two divided doses, followed by dosage increases of one tablet every week up to a maximum dosage of 4 g/day. The dosage escalation was stopped if the participant had papilledema grade \<1 in both eyes, unless the presence of other symptoms such as headache or tinnitus suggested that the dosage escalation should continue. The dosage for the participants who were unable to tolerate the study drug was decreased gradually to a minimum of one half tablet daily.
Weight loss
Behavioral
The weight loss program included a low-calorie diet (≤425 kcal/day) with a target weight loss of approximately 5-10%.

Treatment groups

74 Participants

are divided into 2 treatment groups

Group A: Stent ImplantationExperimental treatment 1 intervention

Group B: Medical TherapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

Perimetric Mean Deviation (PMD)

The change in perimetric mean deviation (PMD) from baseline to 6 month in the eye with the most severe visual loss at baseline.

Time frame

6 months

Secondary outcomes

Cerebrospinal Fluid (CSF) Opening Pressure

The change in intracranial pressure measured by lumbar puncture opening pressure from baseline to 6 months.

Time frame

6 months

Papilledema Grade: Frisén grade(0-5 scores,and higher scores mean worse outcome)

The change in papilledema measured by Frisén grade from baseline to 6 months

Time frame

6 months

Retinal Nerve Fiber Layer Thickness

The change in thickness of retinal nerve fiber layer measured by optical coherence tomography (OCT) from baseline to 6 months.

Time frame

6 months

Total Retinal Thickness

The change in thickness of total retina measured by optical coherence tomography (OCT) from baseline to 6 months.

Time frame

6 months

Other outcomes

Functional health status and quality of life:EuroQol five dimensions questionnaire (EQ-5D,0-100,higher scores mean a better outcome)

The change in functional health status and quality of life measured by EuroQol five dimensions questionnaire (EQ-5D) from baseline to 6 months

Time frame

6 months

Cost-effectiveness analysis (mean costs per patient)

The indicator of cost-effectiveness analysis refers to the mean costs per patient.

Time frame

6 months

Cost-effectiveness analysis (quality-adjusted life years)

The indicator of cost-effectiveness analysis refers to the quality-adjusted life years.

Time frame

6 months

Cost-effectiveness analysis (the cost saving per extra patient with a good outcome)

The indicator of cost-effectiveness analysis refers to the cost saving per extra patient with a good outcome.

Time frame

6 months

Sponsors and contacts

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

Beijing Tiantan Hospital

Lead sponsor

Source ClinicalTrials.gov

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