Imperative Care Launches CLEAR-IT Study to Advance Standards in Peripheral Thromboembolism
Imperative Care, Inc., a medical technology company dedicated to advancing innovative treatments for patients with thromboembolic diseases, has announced a significant milestone in its ongoing clinical research efforts: the enrollment of the first patient in its CLEAR-IT clinical study. This development marks an important step toward improving the understanding and treatment of peripheral thromboembolic conditions, an area where clinical standards remain limited and evolving.
The CLEAR-IT study—short for Long-Term Clinical Evaluation of Aspiration Thrombectomy Using the Symphony or Prodigy Thrombectomy Systems—is a prospective, observational clinical trial designed to evaluate the real-world performance, safety, and clinical outcomes associated with Imperative Care’s Symphony® and Prodigy® Thrombectomy Systems. These devices are engineered to remove blood clots through aspiration-based techniques and are used in minimally invasive endovascular procedures.
The study aims to enroll up to 750 patients across as many as 50 clinical sites throughout the United States. By including a broad and diverse patient population, CLEAR-IT is structured to generate meaningful data across multiple types of peripheral thromboembolic diseases. These include pulmonary embolism (PE), peripheral venous thrombosis, and peripheral arterial thrombosis—conditions that can lead to serious complications, including organ damage, disability, or even death, if not treated promptly and effectively.
According to Emir Deljkich, Senior Vice President of Clinical Affairs at Imperative Care, the CLEAR-IT study reflects the company’s commitment to advancing innovation grounded in strong scientific evidence. He emphasized that while substantial progress has been made in the treatment of acute ischemic stroke—partly due to rigorous clinical trials such as the Imperative Trial—similar advancements are still needed in the peripheral thromboembolism space. The CLEAR-IT study is intended to help close this gap by building a robust body of clinical evidence that can guide future standards of care.
Peripheral thromboembolic diseases represent a complex and varied group of conditions. Pulmonary embolism, for instance, occurs when a blood clot travels to the lungs and blocks a pulmonary artery, potentially causing life-threatening complications. Peripheral venous thrombosis involves clot formation in veins outside the lungs, often in the limbs, while peripheral arterial thrombosis affects arteries and can compromise blood flow to critical tissues. Despite their seriousness, treatment approaches for these conditions can vary widely, and standardized clinical guidelines are still developing.
Endovascular thrombectomy, a minimally invasive procedure that involves removing clots from blood vessels using specialized devices, has emerged as a promising treatment option. Imperative Care’s Symphony and Prodigy systems are designed to enhance this procedure by improving clot removal efficiency while minimizing blood loss and procedure time.
The Symphony Thrombectomy System is a large-bore aspiration device specifically engineered for the treatment of venous thromboembolism (VTE). It utilizes a powerful aspiration mechanism that generates a “Deep Pulse”—a strong vacuum force delivered closer to the clot. This design is intended to improve clot removal efficiency compared to traditional tubing-based systems. Symphony also includes a range of advanced components, such as 16F and 24F catheters that provide stability and flexibility, a ProHelix® Mechanical Assist feature to facilitate clot ingestion, and a long dilator designed to navigate complex vascular anatomy. The system is powered by the Imperative Care Generator, a high-performance aspiration pump.
In contrast, the Prodigy Thrombectomy System is a small-bore aspiration device tailored for arterial thrombectomy procedures. It is designed to offer enhanced precision, control, and consistency, particularly in treating clots in the arteries of the upper and lower extremities. One of its key features is the Gauge, a multifunctional visual chamber that provides real-time feedback to physicians, helping them make informed decisions during the procedure. Prodigy also includes multiple catheter sizes and an innovative asymmetric tip design that improves clot engagement. The Prodigy® Twist component further streamlines clot ingestion without requiring larger catheter sizes.
The CLEAR-IT study is co-led by two prominent clinical experts: Dr. Steven Abramowitz, Chief of Vascular Surgery at MedStar Hospital in Washington, D.C., and Dr. Maya Serhal, an interventional cardiologist and vascular specialist at Massachusetts General Hospital. Their leadership underscores the study’s clinical rigor and its focus on generating outcomes that are both scientifically robust and relevant to real-world practice.
Dr. Abramowitz noted that the study is designed to evaluate how the Symphony and Prodigy systems perform across a wide range of clinical scenarios. By focusing on endpoints that matter to both physicians and patients—such as procedural success, safety, and long-term outcomes—the study aims to produce data that can directly inform clinical decision-making. He expressed confidence that the findings from CLEAR-IT could help establish clearer, evidence-based standards for treating different types of peripheral thromboembolic diseases.
The first patient enrolled in the study was treated by Dr. Dana Tomalty at Huntsville Hospital Health System in Alabama, where she serves as the site’s Principal Investigator. Dr. Tomalty highlighted the encouraging results seen in earlier research, including the SYMPHONY-PE investigational device exemption trial, which demonstrated favorable safety and efficacy outcomes. She also pointed to early real-world experience with the technology, which has shown rapid and effective clot removal with minimal blood loss.
Dr. Tomalty emphasized the importance of collecting independently adjudicated clinical data, noting that such evidence is critical for advancing the field and supporting more informed treatment decisions. She expressed enthusiasm about contributing to a study that has the potential to significantly impact patient care and improve outcomes for individuals with thromboembolic disease.
Ultimately, the CLEAR-IT study represents a major step forward in the effort to standardize and improve the treatment of peripheral thromboembolic conditions. By systematically evaluating advanced thrombectomy technologies in a real-world setting, the study seeks to generate the high-quality evidence needed to guide clinical practice and enhance patient care.
As enrollment progresses and data are collected over time, the insights gained from CLEAR-IT could play a pivotal role in shaping the future of vascular medicine. For patients and healthcare providers alike, this study offers hope for more effective, safer, and more consistent treatment options in an area of medicine that has long faced significant challenges.
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. Imperative Care is based in Campbell, Calif.
