MedTech firm CytoSorbents Corporation ( NASDAQ: CTSO ) announced Monday that Health Canada approved patient enrollment in the country for its pivotal STAR-T trial, which tests the company's DrugSorb-ATR antithrombotic removal system.
The FDA-approved trial, known as Safe and Timely Antithrombotic Removal-Ticagrelor (STAR-T), is currently underway, targeting 120 patients at ~30 study centers in the U.S. and Canada.
It is designed to evaluate if DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving AstraZeneca's ( AZN ) antiplatelet agent ticagrelor during cardiothoracic surgery.
"Canadian cardiac surgery centers are excited to join the STAR-T trial," said Richard Whitlock, Professor of Surgery at McMaster University Medical School and the Population Health Research Institute. Whitlock also serves as the Principal Investigator for the STAR-T trial in Canada.
Dr. Efthymios N. Deliargyris, the medical chief of CytoSorbents ( CTSO ), said that the company is working with the Population Health Research Institute to add up to 7 sites in Canada for the STAR-T trial "as soon as possible."
CytoSorbents ( CTSO ) expects to achieve 80 enrolled patients this Spring and reach full enrollment by Summer 2023."
In December, the company announced that a safety panel of STAR-T recommended the trial be continued without any modifications.
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CytoSorbents says Canada cleared pivotal study for anti-bleeding technology