Neuravi is committed to developing clinical data to advance the treatment of stroke.
In 2015, Neuravi launched a prospective pivotal study, ARISE II (Analysis of Revascularisation in Ischemic Stroke with EmboTrap®), in clinical centres across the US and Europe. ARISE II (ClinicalTrials.gov Identifier: NCT02488915) was designed considering the regulatory requirements for US market clearance. Data from the study will be submitted to U.S. Food and Drug Administration (FDA) in support of an application for market clearance for the EmboTrap® Revascularization Device.
In February 2017, Neuravi completed enrollment in ARISE II. With 228 patients enrolled across the United States and Europe, the study is in the process of following up on the 90 day mRS data for these patients. Dr. Sam Zaidat and Prof. Dr. Tommy Andersson are the US and European principal investigators of the study. Their leadership in study execution is supported by an executive steering committee including world-leading neurologists and neurointerventionalists.
ARISE II Executive Steering Committee
- Dr. Sam Zaidat
- Prof. Tommy Andersson
- Dr. Jeffrey Saver
- Prof. Heinrich Mattle
- Dr. Hormozd Bozorgchami
- Prof. René Chapot
- Dr. Ashutosh Jadhav
- Dr. Tudor Jovin
- Dr. Ana Paula Narata
- Dr. Raul Nogueira
- Dr. Marc Ribó
- Dr. Adnan Siddiqui
- Mairsíl Claffey – VP Clinical, Neuravi
To date there has been extensive clinical evaluation of the EmboTrap in Europe. Neuravi initiated a smaller European trial in 2014, also called ARISE, intended to be a multi-centre European study examining device performance, but the study was terminated short of full enrollment in 2016 to focus efforts onto the larger, international ARISE II study.
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