Venous Sinus Stenting With the River Stent in IIH

NCT03556085 | Active Not Recruiting DMC FDA Device

• 1 other identifier: River 1111-001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 6

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.

Conditions

Idiopathic Intracranial Hypertension

Keywords

idiopathic intracranial hypertension; venous sinus stenting

Outcome Measures

Primary Outcomes (2)

• Major Adverse Event (MAE)

  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)

  12 months

• Clinical improvement with no restenosis of the venous sinus

  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

  12 months

Secondary Outcomes (11)

• Individual components of MAE.

  12 months

• Cerebrospinal fluid (CSF) opening pressure at 12 months

  12 months

• Stent patency at 12 months

  12 months

• Medications

  12 months

• Headaches

  12 months

Study Arms (1)

Venous sinus stenting

EXPERIMENTAL

Subjects will have stenting of the transverse-sigmoid sinus

Device: Venous sinus stenting (Serenity River)

Interventions

Venous sinus stenting (Serenity River) DEVICE

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.

Venous sinus stenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to be eligible for participation in the study:
• Subject is \> 18 year-old and has given informed consent.
• Diagnosis of IIH per Modified Dandy Criteria.
• CSF opening pressure is \> 25 cm H2O.
• 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.
• Presence of IIH clinical symptoms (6. OR 7.)
• 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
• 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.
• 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.
• Catheter manometry shows a pressure gradient \> 8 mm Hg across the transverse sigmoid sinus stenosis.
• Venographic evidence of sinus stenosis (\> 50%)

You may not qualify if:

• Subject must be excluded from participation in this study if any of the following criteria are met
• 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.
• Currently has or plans to have an implanted CSF shunt.
• History of previously implanted intra-cranial sinus stent.
• Transverse-sigmoid sinus vessel size \<5 mm or \>10 mm.
• Creatinine \> 1.5 mg/dl and/or creatinine clearance \< 60 mL/min (except if patients is already on hemodialysis).
• Allergic to imaging contrast media (iodine or gadolinium) despite premedication.
• Allergic to nitinol or nickel.
• Contra-indication to general anesthesia.
• Contra-indication to aspirin, clopidogrel or other anticoagulant.
• Hypercoagulable state (Factor V Leiden, Protein C or S deficiency, Anticardiolipin antibodies, Lupus anticoagulant, B2-glycoprotein-1 antibodies, or Hyperhomocysteinemia).
• Currently requiring full anti-coagulation for other medical reasons, such as atrial fibrillation (AF), artificial valves, deep vein thrombosis pulmonary embolism, etc.
• History of stroke or transient ischemic attack (TIA).
• History of AF or other risks of stroke.
• History of deep vein thrombosis or pulmonary embolism.

Sponsors & Collaborators

• Serenity Medical, Inc.: lead

Study Sites (6)

Baptist Health

Jacksonville, Florida, 32207, United States

Location

UB Neurosurgery

Buffalo, New York, 14203, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (7)

• Albuquerque FC, Gross BA, Levitt MR. Time to re-assess the treatment of idiopathic intracranial hypertension. J Neurointerv Surg. 2016 Jun;8(6):549-50. doi: 10.1136/neurintsurg-2016-012460. No abstract available.

  PMID: 27178402 BACKGROUND

• Abubaker K, Ali Z, Raza K, Bolger C, Rawluk D, O'Brien D. Idiopathic intracranial hypertension: lumboperitoneal shunts versus ventriculoperitoneal shunts--case series and literature review. Br J Neurosurg. 2011 Feb;25(1):94-9. doi: 10.3109/02688697.2010.544781.

  PMID: 21323404 RESULT

• Aguilar-Perez M, Martinez-Moreno R, Kurre W, Wendl C, Bazner H, Ganslandt O, Unsold R, Henkes H. Endovascular treatment of idiopathic intracranial hypertension: retrospective analysis of immediate and long-term results in 51 patients. Neuroradiology. 2017 Mar;59(3):277-287. doi: 10.1007/s00234-017-1783-5. Epub 2017 Mar 2.

  PMID: 28255904 RESULT

• Ahmed RM, Wilkinson M, Parker GD, Thurtell MJ, Macdonald J, McCluskey PJ, Allan R, Dunne V, Hanlon M, Owler BK, Halmagyi GM. Transverse sinus stenting for idiopathic intracranial hypertension: a review of 52 patients and of model predictions. AJNR Am J Neuroradiol. 2011 Sep;32(8):1408-14. doi: 10.3174/ajnr.A2575. Epub 2011 Jul 28.

  PMID: 21799038 RESULT

• Dinkin MJ, Patsalides A. Venous Sinus Stenting in Idiopathic Intracranial Hypertension: Results of a Prospective Trial. J Neuroophthalmol. 2017 Jun;37(2):113-121. doi: 10.1097/WNO.0000000000000426.

  PMID: 27556959 RESULT

• Kanagalingam S, Subramanian PS. Cerebral venous sinus stenting for pseudotumor cerebri: A review. Saudi J Ophthalmol. 2015 Jan-Mar;29(1):3-8. doi: 10.1016/j.sjopt.2014.09.007. Epub 2014 Sep 27.

  PMID: 25859134 RESULT

• Dinkin MJ, Patsalides A. Venous Sinus Stenting for Idiopathic Intracranial Hypertension: Where Are We Now? Neurol Clin. 2017 Feb;35(1):59-81. doi: 10.1016/j.ncl.2016.08.006.

  PMID: 27886896 RESULT

MeSH Terms

Conditions

Pseudotumor Cerebri

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Athos Patsalides, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, single arm, open label clinical study

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 14, 2018
• Study Start: August 24, 2018
• Primary Completion: October 1, 2022
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)