A randomized controlled multicenter clinical investigation to evaluate and compare the safety and efficacy of using ZOOM reperfusion catheters and stent retrievers in thrombectomy procedures to treat acute ischemic stroke patients
This study enrolls people who have been diagnosed with a blood clot blocking an artery in their brain (stroke). The blocked artery is opened by removing the blood clot using a small catheter (thin tube) device that is inserted into an artery through your arm or leg that leads to your brain. The purpose of this study is to find out if this specific new investigational catheter (ZOOM) leads to improved outcomes at 90 days.
This study will last about 90 days. It includes an initial visit with your doctor, where you will undergo bloodwork and brain imaging to see if you are a good fit for this procedure with the ZOOM device. After reviewing results, if you and your doctor would like to move forward the procedure may occur. After the procedure, you will be required to follow up with your doctor just as anyone would who did not participate in this study (standard of care). This includes a follow up at 12-36 hours after procedure, 3 days after, and 90 days after. This study takes place at UBMD Neurosurgery clinics and Buffalo General Medical Center/Gates Vascular Institute in Buffalo NY.
Primary Objective ??? To demonstrate the non-inferiority between the neurovascular thrombectomy device ZOOM Reperfusion Catheter and stent retrievers
for use in the treatment of acute ischemic stroke to improve clinical outcomes.
Secondary Objective ??? To compare the vessel revascularization rate and the rates of perioperative complications between subjects treated with ZOOM Reperfusion Catheter and with stent retrievers.
Adults ages 18+
Diagnosed with a stroke
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