Portland, Oregon 97239


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

River 1111-001


NCT ID:

NCT03556085


Secondary ID:


Study Acronym:


Brief Title:

Venous Sinus Stenting With the River Stent in IIH


Official Title:

Clinical Evaluation of the Serenity River Stent System to Treat Idiopathic Intracranial Hypertension


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Serenity Medical, Inc.


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

39


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Athos Patsalides, MD
Principal Investigator
Weill Cornell Medicine
Primary Contact:Yves P Gobin, MD
914-216-1569
pierre@serenity-medical.com
Backup Contact:Sew-Wah Tay, PhD
612-801-6782
swtay@libramed.com

Study Dates

Start Date:August 24, 2018
Completion Date:March 2020
Completion Type:Anticipated
Primary Completion Date:March 2019
Primary Completion Type:Anticipated
Verification Date:November 2018
Last Changed Date:November 19, 2018
First Received Date:May 22, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Quality of Life NEI-VFQ-25
Time Frame:12 months
Safety Issues:False
Description:Change in quality of life assessed with the National Eye Institute - Visual Functioning Questionnaire - 25 at 12 months compared to baseline.
Outcome Type:Secondary Outcome
Measure:Quality of Life SF-12
Time Frame:12 months
Safety Issues:False
Description:Change in quality of life assessed with the Short Form health survey 12 items (SF-12) at 12 months compared to baseline
Outcome Type:Secondary Outcome
Measure:Tinnitus
Time Frame:12 months
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Retinal Nerve Fiber Layer Thickness
Time Frame:12 months
Safety Issues:False
Description:Change in retinal nerve fiber layer thickness measured using Optical Coherence Tomography (OCT) at 12 months compared to baseline.
Outcome Type:Secondary Outcome
Measure:Visual acuity
Time Frame:12 months
Safety Issues:False
Description:Change in visual acuity using the Early treatment Diabetic Retinopathy (ETDRS) chart at 12 months compared to baseline.
Outcome Type:Secondary Outcome
Measure:Papilledema
Time Frame:12 months
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Headaches
Time Frame:12 months
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Medications
Time Frame:12 months
Safety Issues:False
Description:Change in IIH medications and dosage at 12 months compared to baseline
Outcome Type:Secondary Outcome
Measure:Stent patency at 12 months
Time Frame:12 months
Safety Issues:False
Description:Stent patency will be assessed by retrograde catheter venography. Patency is defined as absence of significant (>50%) stenosis
Outcome Type:Secondary Outcome
Measure:Cerebrospinal fluid (CSF) opening pressure at 12 months
Time Frame:12 months
Safety Issues:False
Description:CSF opening pressure will be measured via lumbar puncture in the lateral decubitus position.
Outcome Type:Secondary Outcome
Measure:Individual components of MAE.
Time Frame:12 months
Safety Issues:False
Description:Components of MAE will be reported as individual event rates.
Outcome Type:Primary Outcome
Measure:Clinical improvement with no restenosis of the venous sinus
Time Frame:12 months
Safety Issues:False
Description:The primary probable benefit endpoint is a composite of: Absence of significant stenosis (defined as >50% stenosis of reference vessel diameter) of the main dural venous sinus on retrograde catheter venography (RCV) AND Trans-stent pressure gradient
Outcome Type:Primary Outcome
Measure:Major Adverse Event (MAE)
Time Frame:12 months
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Device
Name:Venous sinus stenting (Serenity River)
Description: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 t
Arm Name:Venous sinus stenting

Study Arms

Study Arm Type:Experimental
Arm Name:Venous sinus stenting
Description:Subjects will have stenting of the transverse-sigmoid sinus

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Serenity Medical, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:27178402
Reference Type:Results Reference
Citation: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. Review.
PMID:21323404
Reference Type:Results Reference
Citation:Aguilar-Pérez M, Martinez-Moreno R, Kurre W, Wendl C, Bäzner H, Ganslandt O, Unsöld 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
Reference Type:Results Reference
Citation: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
Reference Type:Results Reference
Citation: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
Reference Type:Results Reference
Citation: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. Review.
PMID:25859134
Reference Type:Results Reference
Citation: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. Review.
PMID:27886896

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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