Interventionalists were pre-approved based on training and post-training experience as previously described3 (link). Interventionalists could use any FDA approved device for thrombectomy (approved for use within an 8-hour window following stroke onset and used in the DEFUSE 3 study with an FDA investigational device exemption). The devices used were the Trevo Retriever (Stryker Neurovascular, Fremont CA), the Solitaire Revascularization Device (Medtronic, Irvine, CA), Covidien MindFrame Capture Revascularization Device (Medtronic), and the Penumbra Suction Thrombectomy system (Penumbra, Alameda, CA).
The interventionalist could utilize any device or combination of devices in the ICA or MCA M1 segment. They could also use the devices to remove thrombus from MCA M2 segments. If the interventionalists encountered severe common or proximal ICA stenosis or occlusion, they could also perform angioplasty or stenting with FDA approved devices. Adjuvant intraarterial thrombolytic agents were prohibited in DEFUSE 3.
The interventionalist could utilize any device or combination of devices in the ICA or MCA M1 segment. They could also use the devices to remove thrombus from MCA M2 segments. If the interventionalists encountered severe common or proximal ICA stenosis or occlusion, they could also perform angioplasty or stenting with FDA approved devices. Adjuvant intraarterial thrombolytic agents were prohibited in DEFUSE 3.
