Clinical Education
MicroVention participates in over three dozen 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.
Completed MicroVention 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 MicroVention 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 Microvention 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.
- Hydrogel Clinical Data - North America Brochure
- Hydrogel Clinical Data - International Brochure
- GREAT Trial Results - Worldwide Brochure
- HELPS Trial Results - North America Brochure
- HELPS Trial Results - International Brochure
- Gel the Nec Registry - International Brochure
- HEAT Study - International Brochure
- HEAT Study - North America Brochure
Completed MicroVention 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
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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