Imperative Care has announced the enrolment of the first patient in the Long-Term CLinical Evaluation of Aspiration ThRombectomy Using the Symphony or ProdIgy Thrombectomy Systems (CLEAR-IT) study, a prospective, observational clinical study evaluating the performance of its Symphony and Prodigy thrombectomy systems. This study aims to advance the development of meaningful clinical standards for the treatment of peripheral thromboembolic diseases.
“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, senior vice president of clinical affairs.
“Just as robust clinical data from the Imperative trial has helped establish new standards of care in acute ischaemic stroke, we believe the same level of scientific rigour 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 Symphony and Prodigy thrombectomy systems are aspiration-based technologies used in endovascular thrombectomy procedures across the peripheral and pulmonary vasculature, designed to give physicians greater control to remove more clot in less time while minimising blood loss.
The CLEAR-IT study is expected to enrol up to 750 patients across up to 50 sites in the USA to evaluate the short- and long-term clinical performance and safety of Symphony and Prodigy. By assessing outcomes in pulmonary embolism (PE), peripheral venous thrombosis and peripheral arterial thrombosis, the study will evaluate procedural characteristics and patient outcomes in a real-world setting, with the goal of contributing evidence to inform the development of clinical standards for the treatment of these conditions. The study is co-led by Steven Abramowitz, chief of vascular surgery at MedStar Hospital in Washington DC, USA and Maya Serhal, an interventional cardiologist and vascular interventionalist at Massachusetts General Hospital in Boston, USA.
“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 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.”
The first patient enrolled in the study was treated by Dana Tomalty of Huntsville Hospital Health System in Huntsville, USA, who serves as the site’s principal investigator.
“Following the SYMPHONY-PE investigational device exemption trial, which demonstrated favourable safety and efficacy results, initial real-world experience with this technology has shown fast, effective clot removal with minimal blood loss,” said Tomalty. “We look forward to contributing to independently adjudicated clinical data that have the potential to further advance the field and support more informed clinical decision-making for patients with thromboembolic disease.”
