Imperative Care has enrolled the first patient in its prospective, observational CLEAR-IT study aimed at assessing the performance of the Symphony and Prodigy thrombectomy systems.
The study is designed to build evidence for new clinical standards in treating peripheral thromboembolic diseases such as peripheral venous thrombosis, peripheral arterial thrombosis, and pulmonary embolism (PE).
The Symphony and Prodigy systems are aspiration-based devices intended for use in endovascular procedures across the peripheral and pulmonary vasculature.
These technologies are designed to enable clot removal while minimising blood loss.
CLEAR-IT is expected to enrol up to 750 patients at as many as 50 sites across the US.
It will capture data on both short- and long-term efficacy and safety in real-world cases, focusing on procedural details and patient outcomes for peripheral venous thrombosis, peripheral arterial thrombosis, and PE.
The study is co-led by MedStar Hospital vascular surgery chief Steven Abramowitz and Massachusetts General Hospital interventional cardiologist and vascular interventionalist Maya Serhal.
Huntsville Hospital Health System's principal investigator Dana Tomalty treated the first patient enrolled in the study.
Symphony is a large-bore aspiration device for venous thromboembolism. It features Symphony 24F Advance Long Dilator, ProHelix Mechanical Assist, 16F and 24F catheters, and an aspiration pump.
The Prodigy thrombectomy system is a small-bore system intended for arterial thrombectomy and offers four catheter sizes and a multifunctional visual chamber.
Imperative Care clinical affairs senior vice-president Emir Deljkich said: “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.
“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 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.”
