Imperative Care Launches CLEAR-IT Clinical Study to Advance Standards in Peripheral Thromboembolism Treatment
Imperative Care Inc has announced a significant milestone in its efforts to advance treatment options for patients with thromboembolic diseases, marking the enrollment of the first patient in its CLEAR-IT clinical study. This prospective, observational study is designed to evaluate the real-world performance of the company’s Symphony® and Prodigy® Thrombectomy Systems, with the ultimate goal of helping establish clearer clinical standards for treating peripheral thromboembolic conditions.
The CLEAR-IT study—short for Long-Term Clinical Evaluation of Aspiration Thrombectomy Using the Symphony or Prodigy Thrombectomy Systems—represents an important step in generating high-quality clinical evidence in an area where standardized treatment approaches are still evolving. Peripheral thromboembolic diseases, including pulmonary embolism (PE), peripheral venous thrombosis, and peripheral arterial thrombosis, remain serious and potentially life-threatening conditions that often require rapid and effective intervention. Despite advances in endovascular therapies, there continues to be a need for more robust data to guide clinical decision-making and improve patient outcomes.
According to Emir Deljkich, Senior Vice President of Clinical Affairs at Imperative Care, the launch of the CLEAR-IT study highlights the company’s commitment to combining innovation with rigorous scientific validation. He emphasized that meaningful progress in patient Imperative care depends not only on developing new technologies but also on supporting them with strong clinical evidence. Drawing a parallel to the company’s earlier work in stroke treatment, Deljkich noted that the same level of scientific rigor that helped shape standards of care in acute ischemic stroke is now being applied to the peripheral thromboembolism space.
At the core of the study are the Symphony and Prodigy Thrombectomy Systems, both of which are aspiration-based technologies used in endovascular procedures. These systems are engineered to remove blood clots efficiently from the peripheral and pulmonary vasculature. By utilizing large-bore, vacuum-generated aspiration, the devices are designed to provide physicians with enhanced control during procedures, enabling more effective clot removal in less time while minimizing blood loss. This combination of efficiency and safety is particularly important in managing complex thromboembolic cases, where timely intervention can significantly influence patient outcomes.
The CLEAR-IT study aims to enroll up to 750 patients across as many as 50 clinical sites throughout the United States. By capturing both short-term and long-term data, the study will evaluate not only the safety and effectiveness of the Symphony and Prodigy systems but also procedural characteristics and overall patient outcomes in real-world clinical settings. This broad and inclusive approach is intended to reflect the diversity of cases encountered in everyday medical practice, thereby enhancing the relevance and applicability of the findings.
The study is being co-led by prominent clinical experts, including Steven Abramowitz, M.D., Chief of Vascular Surgery at MedStar Hospital in Washington, D.C., and Maya Serhal, M.D., an interventional cardiologist and vascular specialist at Massachusetts General Hospital. Their leadership brings significant clinical expertise to the study, ensuring that its design and execution are aligned with the needs of both physicians and patients.
Dr. Abramowitz highlighted that the CLEAR-IT study is specifically structured to generate clinically meaningful endpoints that can inform practice across multiple thromboembolic conditions. By evaluating device performance across pulmonary embolism, venous thrombosis, and arterial thrombosis, the study seeks to provide comprehensive insights that could help establish clearer, evidence-based standards for each of these disease areas. Such standards are essential for improving consistency in Imperative care and optimizing treatment strategies across healthcare systems.
The first patient enrolled in the study was treated by Dana Tomalty, M.D., at Huntsville Hospital Health System in Alabama, where she serves as the site’s Principal Investigator. Her participation marks the beginning of what is expected to be a large-scale, multi-center effort to evaluate these technologies in real-world practice.
Dr. Tomalty noted that prior clinical experience with the Symphony system, including findings from the SYMPHONY-PE investigational device exemption trial, has already demonstrated encouraging safety and efficacy results. Early real-world use has further suggested that the technology enables rapid and effective clot removal with minimal blood loss. She expressed optimism that the CLEAR-IT study will build on this foundation by generating independently adjudicated clinical data, which could play a critical role in advancing the field and supporting more informed treatment decisions.
Overall, the initiation of the CLEAR-IT study underscores Imperative Care’s broader mission to address unmet needs in thromboembolic disease management through innovation backed by strong clinical evidence. By focusing on real-world data and comprehensive evaluation across multiple conditions, the study has the potential to significantly influence how peripheral thromboembolic diseases are treated in the future.
As healthcare systems continue to seek more effective and efficient ways to manage complex vascular conditions, studies like CLEAR-IT are essential for bridging the gap between technological innovation and clinical practice. With its scale, design, and focus on meaningful outcomes, the study represents a critical step toward improving patient care and establishing new benchmarks in the treatment of thromboembolic diseases.
About the Symphony Thrombectomy System
The Symphony Thrombectomy System is a large-bore aspiration system engineered to deliver more efficient and effective clot removal in patients with venous thromboembolism (VTE). Symphony is designed to combine large-bore power with precise deep vacuum to provide physicians greater control to remove more clot in less time. By delivering deep vacuum closer to the clot, Symphony generates a Deep Pulse, a powerful pulse of aspiration intended to increase clot removal force compared to a tubing-based system,1 while minimizing blood loss.2
The system includes 16F and 24F catheters for smooth tracking, stability, and telescoping to reach distal anatomy; ProHelix® Mechanical Assist designed to facilitate clot ingestion when needed; the Symphony 24F Advance® Long Dilator for navigating through tortuous anatomy; and the Imperative Care Generator, a powerful aspiration pump.For complete product information, including indications, contraindications, warnings, precautions and adverse events, visit: http://bit.ly/3pAaUlw.
About the Prodigy Thrombectomy System
The Prodigy Thrombectomy System is a small-bore aspiration system designed to bring greater clarity, control and consistency to arterial thrombectomy. Through the Gauge, a multifunctional visual chamber, Prodigy aims to provide physicians with clear, actionable insights to simplify workflows, reduce device time and minimize blood loss. Prodigy is used to treat a wide range of anatomies in both the upper and lower extremities across varying clot morphologies. The system includes four catheter sizes (5F, 6F, 8F, 8F-S) that leverage Imperative Care’s asymmetric tip design; the Prodigy® Twist designed to streamline clot ingestion without upsizing the catheter; and the Imperative Care Generator, a powerful aspiration pump.
About Imperative Care, Inc.
Imperative Care is a commercial-stage medical technology company focused on advancing treatments for patients suffering from thromboembolic disease, a serious medical condition caused by blood clot formation inside veins and arteries. Imperative Care was founded with the mission of bringing lifesaving treatments to patients suffering from ischemic stroke and other devastating vascular diseases caused by blood clot formation.
The company’s commercially available product portfolio includes the Zoom Stroke System, the Symphony Thrombectomy System and the Prodigy Thrombectomy System. In addition to our commercial products, we are developing the Telos robotic platform*, an endovascular robotic system designed to bring greater precision and standardization to procedures and expand access to lifesaving treatment.
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