Imperative Care Launches CLEAR-IT Study to Establish Clinical Standards for Peripheral Thromboembolism Treatment
核心洞察
Imperative Care (搜索) has enrolled the first patient in the CLEAR-IT study, a prospective observational trial evaluating Symphony and Prodigy thrombectomy systems for peripheral thromboembolic diseases.
The study aims to enroll up to 750 patients across 50 U.S. sites to assess real-world performance and safety outcomes for pulmonary embolism (搜索), peripheral venous thrombosis (搜索), and peripheral arterial thrombosis (搜索).
CLEAR-IT represents a critical step toward establishing evidence-based clinical standards for aspiration thrombectomy in peripheral vascular disease treatment.
Imperative Care (搜索) has initiated enrollment in its CLEAR-IT clinical study, marking a significant step toward establishing evidence-based treatment standards for peripheral thromboembolic diseases. The company announced that the first patient has been enrolled in this prospective, observational study designed to evaluate the real-world performance of its Symphony and Prodigy thrombectomy systems.
Study Design and Objectives
The CLEAR-IT study (Long-Term Clinical Evaluation of Aspiration Thrombectomy Using the Symphony or Prodigy Thrombectomy Systems) is expected to enroll up to 750 patients across up to 50 sites in the United States. The study will assess both short- and long-term clinical performance and safety outcomes for patients with peripheral venous thrombosis (搜索), peripheral arterial thrombosis (搜索), and pulmonary embolism (搜索).
"The CLEAR-IT Study underscores Imperative Care (搜索)'s commitment to advancing meaningful innovation grounded in rigorous clinical science to improve patient outcomes and address the unmet needs in peripheral thromboembolism (搜索)," said Emir Deljkich, Senior Vice President of Clinical Affairs at Imperative Care. "Just as robust clinical data from the Imperative Trial has helped establish new standards of care in acute ischemic stroke (搜索), we believe the same level of scientific rigor is essential to advance the peripheral thromboembolism space."
The study is co-led by Steven Abramowitz, M.D., Chief of Vascular Surgery at MedStar Hospital (搜索), Washington DC, and Dr. Maya Serhal, M.D., an interventional cardiologist and vascular interventionalist at Massachusetts General Hospital. The first patient was treated by Dana Tomalty, M.D., of Huntsville Hospital Health System (搜索) in Huntsville, Alabama, who serves as the site's Principal Investigator.
Technology Platform
The Symphony and Prodigy thrombectomy systems represent aspiration-based technologies designed for endovascular thrombectomy procedures across the peripheral and pulmonary vasculature. Both systems are engineered to provide physicians greater control for clot removal while minimizing blood loss.
Symphony Thrombectomy System
The Symphony system is a large-bore aspiration system specifically designed for patients with venous thromboembolism (搜索). The system combines large-bore power with precise deep vacuum to deliver what the company calls a "Deep Pulse" - a powerful pulse of aspiration intended to increase clot removal force compared to tubing-based systems while minimizing blood loss.
Key components include 16F and 24F catheters for smooth tracking and stability, 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 (搜索) Generator aspiration pump.
Prodigy Thrombectomy System
The Prodigy system is a small-bore aspiration system designed for arterial thrombectomy. Through its multifunctional visual chamber called the Gauge, Prodigy aims to provide physicians with clear, actionable insights to simplify workflows, reduce device time and minimize blood loss.
The system includes four catheter sizes (5F, 6F, 8F, 8F-S) that leverage Imperative Care (搜索)'s asymmetric tip design, the Prodigy Twist designed to streamline clot ingestion without upsizing the catheter, and the Imperative Care Generator aspiration pump.
Clinical Significance
Peripheral thromboembolic conditions, including pulmonary embolism (搜索), peripheral venous thrombosis (搜索), and peripheral arterial thrombosis (搜索), pose serious risks for patients and often require endovascular thrombectomy. The CLEAR-IT study is designed to generate high-quality data across multiple disease states to move the field closer to establishing clear clinical standards for treatment.
"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."
Dr. Tomalty noted that following the SYMPHONY-PE investigational device exemption trial, which demonstrated favorable safety and efficacy results, initial real-world experience with this technology has shown fast, effective clot removal with minimal blood loss. "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 (搜索)," she said.
The study represents what Deljkich described as "a critical step in building clinical evidence to support large-bore, vacuum-generated aspiration thrombectomy for venous thromboembolism (搜索), as well as the evaluation of novel device designs for arterial thromboembolism."