Penumbra has announced the enrolment of the first patient into the CHEETAH study, a prospective, multicentre US study to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in coronary vessels.
A press release from the company states that the Indigo CAT RX Aspiration Catheters and Indigo Separator 4, which were introduced in 2018 as part of the Indigo Aspiration System, are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The Indigo CAT RX is a 6Fr-compatible, rapid exchange catheter designed for maximised clot removal with its large aspiration lumen, and engineered for advanced trackability and deliverability as a result of seven material transitions and a proximal laser cut hypotube. The proprietary Separator 4 may be used together with the Indigo CAT RX for mechanical clot engagement.
The press release indicates that the Indigo System CAT RX device uses mechanical power aspiration to remove thrombus in the coronaries. The postmarket, prospective CHEETAH study will enrol up to 400 patients presenting with coronary thrombus who are referred for percutaneous coronary intervention (PCI) at up to 25 US centres. The primary study endpoint is a composition of cardiovascular (CV) death, recurrent myocardial infarction (MI), cardiogenic shock, or new or worsening New York Heart Association (NYHA) Class IV heart failure within 30 days. Secondary endpoints include final TIMI flow grade, final TIMI thrombus grade, and safety assessments at six months.
National principal investigator S Jay Mathews (Manatee Memorial Hospital, Bradenton, Florida, USA) indicates in the press release: “Penumbra has adapted over 10 years of neuro hrombectomy experience to address the limitations of traditional manual aspiration for the coronaries by development of the Indigo System CAT RX device. This significant upgrade in innovation from syringe-based aspiration to mechanical power aspiration coupled with highly trackable catheter technology has enabled us to improve our door to reperfusion times and thereby to improve patient care.”
And Jasvindar Singh (Barnes Jewish Hospital/ Washington University School of Medicine, St. Louis, USA) adds: “The CHEETAH study is the first step toward making coronary mechanical thrombectomy standard of care for high thrombus burden patients. We expect this study to refine our technique of thrombus aspiration and better understand the utilisation of CAT RX for patients with high thrombus burden.”