Idiopathic Intracranial HypotensionPhase 3NCT05707442
Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)
A Phase 3 study testing Stent Implantation, Acetazolamide-based medical therapy and Weight loss in people with Idiopathic Intracranial Hypotension and Venous Sinus Stenosis, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Idiopathic Intracranial Hypotension, Venous Sinus Stenosis
- What is being tested?
- Stent Implantation, Acetazolamide-based medical therapy and Weight loss
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2023to Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- 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
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- 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)
Who cannot join
- 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)
- Other condition requiring the use of diuretics, steroids or other drugs to reduce intracranial pressure
- DSA showed diffused venous sinus stenosis, cortical or deep vein stenosis
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- A history of severe thyroid disease and iodine allergy
- Pregnant or lactating women
- Severe cardiopulmonary, liver or kidney failure
- Known hereditary or acquired haemorrhagic diathesis
- Known hereditary or acquired thrombophilia
- Platelet counts or coagulation abnormality
- Major surgery or severe trauma or any traumatic brain injury within the previous 14 days
- A history of cerebral hemorrhage, arteriovenous malformation, intracranial aneurysm or tumor
- Other life threatening illness (eg, advanced cancer) likely to lead to death within a few months; the physical, psychological and social status of patients may affect follow-up (eg, drug addiction, advanced malignant disease, no telephone, no family, etc); cannot tolerate general anesthesia
- Increased intracranial pressure due to other secondary factors
- Ophthalmic Exclusion Criteria:
- Current intraocular pressure > 28mmHg or previous intraocular pressure > 30mmHg
- Refractive error spherical power greater than -6.0D or +6.0D and astigmatism greater than 3.0D, except for the following cases:
- Myopia of - 6.0D to - 8.0D with the following: 1)There was no myopia related disease that can lead to decreased vision under the eyeground microscope (eg, scleral staphyloma, retinal thinning at the posterior pole, and moderate to severe disc tilt); 2) The patient wore contact lenses of appropriate degree for all visual field examinations.
- Hyperopia of +6.0D to +8.0D with the following: 1) The presence of a well characterized peri optic disc edematous halo, as opposed to crowded small optic discs or other features of decreased visual acuity associated with hyperopic changes, was at the discretion of the site investigator or reading center leader (or his designee); 2) The patient wore contact lenses of appropriate degree for all visual field examinations.
- Examination visible or past medical history known to have large optic disc drusen (persistent optic disc edema can present with small optic disc drusen, as low numbers are acceptable for inclusion and to be determined by the investigator to be unrelated to vision loss)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100010
Dapeng Mo, MD, +8613691419036, modapeng1971@163.com
About this study
The aim of this study is to assess the efficacy of stent implantation versus medical therapy on idiopathic intracranial hypertension with venous sinus stenosis.
Read the detailed description
The SIMPLE is a multicentered, prospective, randomized, open-label, blinded end-point clinical trial. A total of 74 patients with idiopathic intracranial hypertension (IIH) and venous sinus stenosis (VSS) for more than 2 months will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups (stenting or medical therapy) after offering informed content.
- Being tested
- Stent Implantation, Acetazolamide-based medical therapy, Weight loss
- Keywords
- Idiopathic intracranial hypertension, Venous sinus stenosis, Stenting, Medical therapy, Randomized controlled trial
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent ImplantationProcedure or 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 therapyDrug
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 lossBehavioural
The weight loss program included a low-calorie diet (≤425 kcal/day) with a target weight loss of approximately 5-10%.
| Study group | Role | What they receive |
|---|---|---|
| Stent Implantation | Experimental | 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. Receives: Procedure: Stent Implantation |
| Medical Therapy | Active comparator | 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%. Receives: Drug: Acetazolamide-based medical therapy; Behavioral: Weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (8)
Cerebrospinal Fluid (CSF) Opening Pressure
The change in intracranial pressure measured by lumbar puncture opening pressure from baseline to 6 months.
Measured: 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
Measured: 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.
Measured: 6 months
Total Retinal Thickness
The change in thickness of total retina measured by optical coherence tomography (OCT) from baseline to 6 months.
Measured: 6 months
Visual Acuity: National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25, minimum and maximum values: 0-100 points, higher scores mean a better visual function)
The change in vision measured by National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) from baseline to 6 months.
Measured: 6 months
Visual Acuity: 10-item neuro-ophthalmic supplement to the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) (minimum and maximum values: 0-100 points, higher scores mean a better visual function)
The change in vision measured by 10-item neuro-ophthalmic supplement to the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25)from baseline to 6 months.
Measured: 6 months
Headache: Headache Impact Test-6 (HIT-6, minimum and maximum values: 36-78 points, higher scores mean greater headache severity)
The change in headache measured by Headache Impact Test-6 (HIT-6) questionnaire from baseline to 6 months.
Measured: 6 months
Pulsatile tinnitus: Tinnitus Handicap Inventory (THI, minimum and maximum values: 0-100 points, higher scores mean more serious tinnitus disability)
The change in pulsatile tinnitus from baseline to 6 months；pulsatile tinnitus was assessed using the Tinnitus Handicap Inventory (THI), which is a self-report measure that can be used in a busy clinical practice to quantify the impact of tinnitus on daily living.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start16 Feb 2023
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Intracranial HypotensionStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dapeng Mo, Beijing Tiantan Hospital
- Investigators
- Dapeng Mo, MD, Principal investigator, Beijing Tiantan HospitalZhongrong Miao, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707442
- Sponsor's protocol ID
- HX-A-2022042
- Status last verified
- Feb 2026
- First submitted
- 25 Dec 2022
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)
- ClinicalTrials.gov ID
- NCT05707442
- Acronym / sponsor ID
- HX-A-2022042
- Keywords
- Idiopathic intracranial hypertension, Venous sinus stenosis, Stenting, Medical therapy, Randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the efficacy of stent implantation versus medical therapy on idiopathic intracranial hypertension with venous sinus stenosis.
Detailed description
The SIMPLE is a multicentered, prospective, randomized, open-label, blinded end-point clinical trial. A total of 74 patients with idiopathic intracranial hypertension (IIH) and venous sinus stenosis (VSS) for more than 2 months will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups (stenting or medical therapy) after offering informed content.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent Implantation | Experimental | Procedure: Stent ImplantationThe 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. |
| Medical Therapy | Active comparator | Drug: Acetazolamide-based medical therapy, Behavioral: Weight lossThe 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%. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subject Eligibility Criteria
- Ophthalmic Eligibility Criteria:
Key exclusion criteria (22 listed)
- Subject Exclusion Criteria
- Ophthalmic Exclusion Criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent ImplantationAspirin (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). | Procedure or surgery | Stent Implantation |
| Acetazolamide-based medical therapyThe 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. | Drug | Medical Therapy |
| Weight lossThe weight loss program included a low-calorie diet (≤425 kcal/day) with a target weight loss of approximately 5-10%. | Behavioural | Medical Therapy |
Primary outcome
Perimetric Mean Deviation (PMD)
Time frame: 6 months
The change in perimetric mean deviation (PMD) from baseline to 6 month in the eye with the most severe visual loss at baseline.
8 secondary outcomes
Cerebrospinal Fluid (CSF) Opening Pressure
Time frame: 6 months
Papilledema Grade: Frisén grade(0-5 scores,and higher scores mean worse outcome)
Time frame: 6 months
Retinal Nerve Fiber Layer Thickness
Time frame: 6 months
Total Retinal Thickness
Time frame: 6 months
Visual Acuity: National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25, minimum and maximum values: 0-100 points, higher scores mean a better visual function)
Time frame: 6 months
Visual Acuity: 10-item neuro-ophthalmic supplement to the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) (minimum and maximum values: 0-100 points, higher scores mean a better visual function)
Time frame: 6 months
Headache: Headache Impact Test-6 (HIT-6, minimum and maximum values: 36-78 points, higher scores mean greater headache severity)
Time frame: 6 months
Pulsatile tinnitus: Tinnitus Handicap Inventory (THI, minimum and maximum values: 0-100 points, higher scores mean more serious tinnitus disability)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dapeng Mo, MD principal investigator
Beijing Tiantan Hospital
Zhongrong Miao, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stent Implantation, Acetazolamide-based medical therapy and Weight loss in people with Idiopathic Intracranial Hypotension and Venous Sinus Stenosis, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xu Tong, MD (+8617611338800, dongri0514@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perimetric Mean Deviation (PMD) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.