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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Subject Eligibility Criteria

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

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

⁃ Normal cerebrospinal fluid (CSF) composition

⁃ Neuroimaging showing normal brain parenchyma without hydrocephalus, mass, or any structural lesion and no evidence of meningeal enhancement on CT or MRI

⁃ Localized venous sinus stenosis (VSS) with stenotic degree ≥ 50% on DSA, and pressure gradient across stenosis ≥ 8 mmHg

⁃ Patients or their relatives signed written informed consent

• Ophthalmic Eligibility Criteria:

‣ At least one eye had the presence of papilledema

⁃ At least one eye of visual field loss: PMD ranging from - 2dB and below; decreased visual function on automated perimetry was reproducible with a false-positive rate of no more than 15%

⁃ Visual acuity above 20 / 200 (≥ 39 letters)

Locations
Other Locations
China
Beijing Tiantan Hospital
RECRUITING
Beijing
Contact Information
Primary
Xu Tong, MD
dongri0514@sina.com
+8617611338800
Time Frame
Start Date: 2022-10-31
Estimated Completion Date: 2026-12
Participants
Target number of participants: 74
Treatments
Experimental: Stent Implantation
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.
Active_comparator: Medical Therapy
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. In addition, the weight loss program included a low-calorie diet (≤425 kcal/day) with a target weight loss of approximately 5-10%.
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov