Venous Sinus Stenting With the River Stent in IIH

NAActive, not recruitingINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

August 24, 2018

Primary Completion Date

October 1, 2022

Study Completion Date

November 1, 2026

Conditions
Idiopathic Intracranial Hypertension
Interventions
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.

Trial Locations (6)

10065

Weill Cornell Medicine, New York

11030

Northwell Health, Manhasset

14203

UB Neurosurgery, Buffalo

27157

Wake Forest University Health Sciences, Winston-Salem

32207

Baptist Health, Jacksonville

97239

Oregon Health & Science University, Portland

All Listed Sponsors
lead

Serenity Medical, Inc.

INDUSTRY

NCT03556085 - Venous Sinus Stenting With the River Stent in IIH | Biotech Hunter | Biotech Hunter