The Gore Reduce clinical study is a prospective, randomized, multi-center, multinational trial designed to demonstrate safety and effectiveness of the Gore Helex Septal Occluder for patent foramen ovale (PFO) closure in patients with a PFO and history of cryptogenic stroke or imaging confirmed transient ischemic attack (TIA).
Patients will be randomized to one of two treatment arms, either antiplatelet medical management alone or device closure of the PFO in conjunction with antiplatelet medical management. The primary endpoint is freedom from recurrent ischemic stroke, imaging confirmed TIA, or death due to stroke through 24 months post-randomization. The study sponsor is currently recruiting up to 50 investigational sites in the US and Nordic countries.
The trial is unique based on the participation of Nordic investigational sites, the use of imaging confirmed stroke and TIA for assessing its primary endpoint, a 2:1 device to medical management randomization strategy, and the use of the Gore Helex Septal Occluder.