Imperative Care Begins CLEAR-IT Study of Thrombectomy Systems

Imperative Care has enrolled the first patient in its CLEAR-IT study, which will assess the performance of its Symphony and Prodigy thrombectomy systems.

The study hopes to advance development of meaningful clinical standards to treat peripheral thromboembolic diseases. The Symphony and Prodigy Thrombectomy systems are aspiration-based technologies used in endovascular thrombectomy across the peripheral and pulmonary vasculature, engineered to give physicians greater control to remove more clot in less time while minimizing blood loss.

“The CLEAR-IT Study underscores Imperative Care’s commitment to advancing meaningful innovation grounded in rigorous clinical science to improve patient outcomes and address the unmet needs in peripheral thromboembolism,” said Emir Deljkich, Imperative Care’s senior VP of clinical affairs. “Just as robust clinical data from the Imperative Trial has helped establish new standards of care in acute ischemic stroke, we believe the same level of scientific rigor is essential to advance the peripheral thromboembolism space. This study represents a critical step in building clinical evidence to support large-bore, vacuum-generated aspiration thrombectomy for venous thromboembolism, as well as the evaluation of novel device designs for arterial thromboembolism.”

The CLEAR-IT study (Long-Term CLinical Evaluation of Aspiration ThRombectomy Using the Symphony or ProdIgy Thrombectomy Systems) will enroll up to 750 patients at up to 50 U.S. sites. By assessing outcomes in PE, peripheral venous thrombosis, and peripheral arterial thrombosis, the study will evaluate procedural characteristics and patient outcomes in a real-world setting.

The study is co-led by Steven Abramowitz, MD, Chief of Vascular Surgery at MedStar Hospital, Washington DC, and Dr. Maya Serhal, MD, an interventional cardiologist and vascular interventionalist at Massachusetts General Hospital.

“CLEAR-IT is designed to evaluate how Symphony and Prodigy perform across a broad range of peripheral thromboembolic conditions in real-world clinical practice,” said Dr. Abramowitz. “This study is structured to drive clinically meaningful endpoints that matter to physicians and patients. By generating high-quality data across multiple disease states, we believe the CLEAR-IT study can move the field closer to establishing clear clinical standards for the treatment of each of these respective diseases.”

Last week, the company closed an oversubscribed $100 million convertible note financing to support continued commercialization of its stroke and vascular thrombectomy portfolios.