Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 37 for:    idiopathic intracranial hypertension

Venous Sinus Stenting With the River Stent in IIH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03556085
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Serenity Medical, Inc.

Brief Summary:

The objective of the study is to show that stenting the transverse-sigmoid sinus with the River stent is safe and has probable benefit to relieve clinical symptoms in subjects with idiopathic intracranial hypertension (IIH).

The study will enroll 39 IIH subjects with moderate to severe visual field loss or severe headaches that have failed medical therapy.

The primary safety endpoint is the rate of major adverse event at 12 months The primary probable benefit endpoint is a composite at 12 months of absence of significant sinus stenosis and clinically relevant improvement.


Condition or disease Intervention/treatment Phase
Idiopathic Intracranial Hypertension Device: Venous sinus stenting (Serenity River) Not Applicable

Detailed Description:

Study objective: The objective of the study is to show that stenting the transverse-sigmoid sinus with the River stent is safe and has probable benefit to relieve clinical symptoms in subjects with idiopathic intracranial hypertension (IIH)

Investigational product: Serenity River Stent System

Study design: prospective, multicenter, single arm, open label clinical trial

Subject population: IIH subjects with significant (>50%) stenosis of the transverse-sigmoid sinuses and moderate to severe visual field loss or severe headaches that have failed medical therapy. In the absence of this trial, subjects would have been offered a surgical treatment of IIH such as sinus stenting with an off-label device, cerebrospinal fluid shunting, or optic nerve sheath fenestration by the treating physician.

  • For subjects with visual field loss: if moderate to severe visual field loss (mean deviation between -6db and -30 db) for at least 2 weeks despite escalation of acetazolamide to 1000 mg twice a day or if the visual field deteriorates by more than 2 db during treatment, or treatment intolerance.
  • For subjects with headaches: if they have severe headaches (HIT > 59) for at least 4 weeks despite treatment with topiramate 100 mg twice a day or other headache medication, or treatment intolerance.

Enrollment size and sites: 39 subjects will be enrolled in up to 10 US sites.

Primary safety endpoint: Major Adverse Event at 12 months. The MAE is a composite of the following: moderate or severe stroke (NIHSS > 3), neurological death, perforation or thrombosis of sinus or cerebral vein, device distal embolization, need for target lesion revascularization or need for alternate IIH surgical procedure such as cerebrospinal fluid shunting or optic nerve sheath fenestration.

Primary probable benefit endpoint: a composite at 12 months of:

  • Absence of significant (>50%) stenosis of the stented sinus on retrograde catheter venography and
  • Trans-stent pressure gradient < 8 mm Hg and
  • Clinically relevant improvement in the main clinical outcome per specific inclusion criteria and stabilization or better of the other:

    • Headaches: if the specific inclusion criteria was headaches, improvement in the HIT- 6 scale by > 4 points and improvement or stabilization of visual field.
    • Ophthalmic: if the specific inclusion criteria was visual field loss, improvement of visual field by > 29% of the baseline value in the study eye, stabilization or improvement in the fellow eye, and improvement or stabilization of headaches.

Study duration and follow-up: The subjects will be followed at 2 weeks, 3 months, 6 months and 12 months. At 12 months, clinical examination, lumbar puncture and retrograde catheter venography with manometry will be performed to evaluate the patency of the treated sinus and the absence of trans-stent pressure gradient. Subjects will be consented to be clinically followed annually for up to 5 years.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, multicenter, single arm, open label clinical study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Serenity River Stent System to Treat Idiopathic Intracranial Hypertension
Actual Study Start Date : August 24, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Venous sinus stenting
Subjects will have stenting of the transverse-sigmoid sinus
Device: Venous sinus stenting (Serenity River)
Patient is placed under general anesthesia. From femoral vein access, a standard guide-catheter is advanced in the internal jugular vein (on the side considered for stenting). The sigmoid then transverse sinus is catheterized with a microcatheter and guide-wire and an exchange guide-wire is placed in the superior sagittal sinus. The River stent delivery catheter is advanced over the exchange guide-wire in the sigmoid then transverse sinus up to the torcula. The River stent is deployed to cover the entire transverse sinus and the proximal half of the sigmoid sinus. The catheters are removed and hemostasis obtained by using a closure device or manual compression. The patient is kept overnight in the hospital for observation.




Primary Outcome Measures :
  1. Major Adverse Event (MAE) [ Time Frame: 12 months ]

    The MAE is a composite of the following:

    Moderate or severe stroke (NIH stroke scale > 3) Neurological death Perforation of sinus or cerebral vein Thrombosis of sinus or cerebral vein Device distal embolization Need for target lesion revascularization or need for IIH alternate procedure (cerebrospinal fluid shunting or optic nerve sheath fenestration)


  2. Clinical improvement with no restenosis of the venous sinus [ Time Frame: 12 months ]

    The primary probable benefit endpoint is a composite of:

    1. Absence of significant stenosis (defined as >50% stenosis of reference vessel diameter) of the main dural venous sinus on retrograde catheter venography (RCV) AND
    2. Trans-stent pressure gradient (measured during the RCV) < 8 mm Hg AND
    3. Clinically relevant improvement in the main clinical outcome per specific inclusion criteria (headache or ophthalmic) and stabilization or better of the other


Secondary Outcome Measures :
  1. Individual components of MAE. [ Time Frame: 12 months ]
    Components of MAE will be reported as individual event rates.

  2. Cerebrospinal fluid (CSF) opening pressure at 12 months [ Time Frame: 12 months ]
    CSF opening pressure will be measured via lumbar puncture in the lateral decubitus position.

  3. Stent patency at 12 months [ Time Frame: 12 months ]
    Stent patency will be assessed by retrograde catheter venography. Patency is defined as absence of significant (>50%) stenosis

  4. Medications [ Time Frame: 12 months ]
    Change in IIH medications and dosage at 12 months compared to baseline

  5. Headaches [ Time Frame: 12 months ]
    Change in headaches assessed using the Headache Impact Test (HIT-6) scale (minimum score 36, maximum 78; higher value represents worse headache) at 12 months compared to baseline.

  6. Papilledema [ Time Frame: 12 months ]
    Change in papilledema grading using Frisen scale (Stage 0 to 5; stage 0 represents no papilledema and is the best outcome) at 12 months compared to baseline.

  7. Visual acuity [ Time Frame: 12 months ]
    Change in visual acuity using the Early treatment Diabetic Retinopathy (ETDRS) chart at 12 months compared to baseline.

  8. Retinal Nerve Fiber Layer Thickness [ Time Frame: 12 months ]
    Change in retinal nerve fiber layer thickness measured using Optical Coherence Tomography (OCT) at 12 months compared to baseline.

  9. Tinnitus [ Time Frame: 12 months ]
    Change in the intensity of tinnitus evaluated on the Tinnitus Functional Index (TFI) score (overall score; minimum 0, maximum 100; 100 is the worst tinnitus with the worst negative impact) at 12 months compared to baseline.

  10. Quality of Life SF-12 [ Time Frame: 12 months ]
    Change in quality of life assessed with the Short Form health survey 12 items (SF-12) at 12 months compared to baseline

  11. Quality of Life NEI-VFQ-25 [ Time Frame: 12 months ]
    Change in quality of life assessed with the National Eye Institute - Visual Functioning Questionnaire - 25 at 12 months compared to baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for participation in the study:

  1. Subject is > 18 year-old and has given informed consent.
  2. Diagnosis of IIH per Modified Dandy Criteria.
  3. CSF opening pressure is > 25 cm H2O.
  4. Radiological examination (magnetic resonance venography (MRV) or computed tomographic venography (CTV)) shows bilateral transverse-sigmoid venous sinus stenosis (> 50%) or unilateral stenosis of the dominant sinus with contralateral hypoplastic sinus.
  5. Presence of IIH clinical symptoms (6. OR 7.)
  6. Headaches: Score > 59 (severe impact) on the HIT-6 scale, refractory to medical therapy (e.g. acetazolamide 1000 mg twice daily, topiramate 100 mg twice daily, or other headache medication) for ≥ 4 weeks, or treatment intolerance OR
  7. Visual field loss: defined by perimetric mean deviation (PMD) between -6 dB and -30 dB in one or both eyes (with papilledema Grade >1) despite at least 2 weeks of medical therapy with acetazolamide 1000 mg twice daily, or if the visual field deteriorates by more than 2 dB during treatment, or treatment intolerance.
  8. In the absence of this study, the subject would have been offered a surgical intervention by Optic Nerve Sheath Fenestration (ONSF), Cerebro Spinal Fluid (CSF) shunting procedure, or venous sinus stenting with an off-label device.
  9. Catheter manometry shows a pressure gradient > 8 mm Hg across the transverse sigmoid sinus stenosis.
  10. Venographic evidence of sinus stenosis (> 50%)

Exclusion Criteria:

Subject must be excluded from participation in this study if any of the following criteria are met

  1. Subjects presenting with de novo papilledema and severe visual field(VF) deficit (VF loss > -15db) that requires immediate surgical treatment without prior attempt of medical therapy.
  2. Currently has or plans to have an implanted CSF shunt.
  3. History of previously implanted intra-cranial sinus stent.
  4. Transverse-sigmoid sinus vessel size <5 mm or >10 mm.
  5. Creatinine > 1.5 mg/dl and/or creatinine clearance < 60 mL/min (except if patients is already on hemodialysis).
  6. Allergic to imaging contrast media (iodine or gadolinium) despite premedication.
  7. Allergic to nitinol or nickel.
  8. Contra-indication to general anesthesia.
  9. Contra-indication to aspirin, clopidogrel or other anticoagulant.
  10. Hypercoagulable state (Factor V Leiden, Protein C or S deficiency, Anticardiolipin antibodies, Lupus anticoagulant, B2-glycoprotein-1 antibodies, or Hyperhomocysteinemia).
  11. Currently requiring full anti-coagulation for other medical reasons, such as atrial fibrillation (AF), artificial valves, deep vein thrombosis pulmonary embolism, etc.
  12. History of stroke or transient ischemic attack (TIA).
  13. History of AF or other risks of stroke.
  14. History of deep vein thrombosis or pulmonary embolism.
  15. History of chronic obstructive pulmonary disease or other severe respiratory disease.
  16. History of severe carotid atherosclerotic disease.
  17. History of heart failure, dilated cardiomyopathy, or congenital heart conditions, etc. that are at high thrombogenic risk.
  18. History of uncontrolled diabetes.
  19. Use of tetracycline derivative, retinoid or vitamin A during the last 3 months.
  20. Cerebral vascular lesions (arteriovenous malformation (AVM), arteriovenous fistula, aneurysms, significant stenosis of extra- or intra-cranial vessels other than the targeted venous sinus stenosis,intracranial artery dissection, etc.).
  21. Patient has visions loss due to other disease (e.g. cataract, macular degeneration, glaucoma, etc.).
  22. Inability to provide reliable and reproducible visual field examinations (>15% false positive errors and/or failure to maintain fixation for eye monitoring).
  23. For female subject of child bearing potential, pregnant or not willing to use contraception for 12 months.
  24. Presence of a physical, mental or social condition that could prevent adequate one-year follow-up (homelessness, drug dependency, anticipation of moving far away, life threatening disease, terminal illness).
  25. Anatomical anomaly of the venous sinus which would prevent safe catheterization and stenting (e.g multi-channel sinus)
  26. Currently enrolled in a premarket investigational study. Enrollment in a post market study that does not impact the River™ Stent procedure or device is allowed.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556085


Contacts
Layout table for location contacts
Contact: Yves P Gobin, MD 914-216-1569 pierre@serenity-medical.com
Contact: Sew-Wah Tay, PhD 612-801-6782 swtay@libramed.com

Locations
Layout table for location information
United States, New York
UB Neurosurgery Recruiting
Buffalo, New York, United States, 14203
Contact: Jennifer Gay    716-929-9643    jgay@ubns.com   
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Athos Patsalides, MD    212-746-2821    kas2004@med.cornell.edu   
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Kelsey Launchbury    503-418-1722    nadeauk@ohsu.edu   
Sponsors and Collaborators
Serenity Medical, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Athos Patsalides, MD Weill Cornell Medicine

Publications of Results:

Other Publications:
Layout table for additonal information
Responsible Party: Serenity Medical, Inc.
ClinicalTrials.gov Identifier: NCT03556085     History of Changes
Other Study ID Numbers: River 1111-001
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Serenity Medical, Inc.:
idiopathic intracranial hypertension
venous sinus stenting

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Intracranial Hypertension
Pseudotumor Cerebri
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases