Supira System for Coronary Artery Disease

(SUPPORT II Trial)

This trial tests a new device called the Supira System, which might assist people with coronary artery disease undergoing a procedure known as HRPCI. The main goal is to determine if the Supira System can safely support the heart during this procedure, compared to another device called Impella. The trial seeks participants who are stable and scheduled for HRPCI where heart support is necessary. Individuals with recent strokes, severe heart or liver issues, or certain allergies cannot join. As an unphased trial, this study offers a unique opportunity to contribute to the development of innovative heart support technology.

The trial protocol does not specify if you need to stop your current medications. However, if you are on antiplatelet or anticoagulant therapy, you may need to continue them unless there's a specific reason to stop within 90 days of the procedure.

In earlier studies, the Supira System demonstrated promising safety results. Research indicates that it provides temporary heart support during high-risk procedures without major complications. For example, one study found that patients used the Supira System for an average of 109 minutes without experiencing serious drops in blood pressure requiring additional medication. These findings suggest the device is well-tolerated. Additionally, other studies have shown that the device operates reliably and safely. While these results are encouraging, the Supira System is still undergoing testing to confirm these findings.¹²³⁴⁵

The Supira System is unique because it offers a novel approach to treating coronary artery disease. Unlike traditional treatments like stents or bypass surgery, which physically open or bypass blocked arteries, the Supira System may use an advanced mechanical assistance device to support heart function, potentially reducing the heart's workload during critical moments. Researchers are excited because this system could offer a less invasive and more immediate support option compared to the current standard of care. By focusing on enhancing cardiac output mechanically, the Supira System might improve patient outcomes without the need for more invasive procedures.

Research has shown that the Supira System, which participants in this trial may receive, holds promise for patients undergoing high-risk heart procedures. One study found that 93% of patients using the Supira System experienced successful outcomes, with their hearts supported steadily for up to 72 hours or until hospital discharge. Another study demonstrated that the system effectively supported the heart during procedures without causing significant drops in blood pressure. The Supira System is small and provides continuous blood flow, helping to maintain heart function safely during challenging procedures. These findings suggest the Supira System could be a viable option for temporary heart support in patients facing high-risk procedures. Meanwhile, another group in this trial will receive the Impella, which serves as an active comparator.¹²³⁴⁶