Completed Terumo Neuro Clinical Trials
GREAT Study: Second-Generation Hydrogel Coils for the Endovascular Treatment of Intracranial Aneurysms - A Randomized Controlled Trial.
HELPS: Hydrogel-coated coils versus bare platinum coils for the endovascular treatment of intracranial aneurysms.
Gel the Nec Registry: To assess the safety and efficacy of HydroSoft™ coils in treating intracranial aneurysms when deployed at the aneurysm neck as a finishing coil (≤3 mm).
HEAT Trial: New Generation Hydrogel Endovascular Aneurysm Treatment Trial.
Ongoing Terumo Neuro Clinical Trials
RAGE: A registry to determine safety and occlusion rates when second-generation hydrogel coils are used in the treatment of ruptured intracranial aneurysms.
COAST: A multi-center post-marketing study to establish the acute and sustained efficacy of EVT of small intracranial aneurysms with the specified microcoils, aided by balloon and/or stent remodeling where appropriate. In Phase 1 with Terumo Neuro HyperSoft™ 3D and HyperSoft™ helical coils with or without balloon remodeling or stent assistance at the discretion of the treating physician. In Phase 2 the aneurysm must be framed with HydroSoft™ 3D and finished with HyperSoft™ 3D and/or HyperSoft™ helical coils.
Completed Terumo Neuro Clinical Trials
The SAFE Study: Safety and Efficacy Analysis of FRED™ Embolic Device in Aneurysm Treatment: One-year Clinical and Anatomical Results
The EuFRED Study: European Multicenter Study for the Evaluation of a Dual-Layer Flow- Diverting Stent for Treatment of Wide-Neck Intracranial Aneurysms. The European Flow-Redirection Intraluminal Device Study
Brazilian FRED Registry: A Prospective Multicenter Study for Brain Aneurysm Treatment—The BRED Study
FRED™ & Pipeline Matched Cohort Analysis: Comparison of Pipeline Embolization Device and Flow Re-Direction Endoluminal Device Flow Diverters for Internal Carotid Artery
Aneurysms: A Propensity Score-Matched Cohort Study
LVIS™ PMA Pivotal Study: LVIS™ PMA Pivotal Study is a prospective, multi-center, interventional GCP study completed in the United States
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Clinical Education
Terumo Neuro participates in global clinical studies in order to establish the safety and efficacy of the products we develop, sell and license. Research provides real world data and experience that drives the adoption of emerging technologies. Please see below for information on our ongoing and completed clinical trials.