Medistim ASA has announced the launch of the PATENT study, a prospective, multicenter trial designed to evaluate the clinical benefits of intraoperative completion control using transit time flow measurement (TTFM) and high-frequency ultrasound (HFUS) imaging in patients undergoing bypass surgery for Critical Limb Threatening Ischemia (CLTI) below the knee. The study aims to improve surgical outcomes and reduce the risk of limb amputation in this patient population.
Study Design and Objectives
The PATENT study will enroll approximately 450 patients across 15 sites in the USA, Europe, and Asia. Patient enrollment is scheduled to begin by the end of 2024, with a recruitment period of around two years. Each patient will be followed for 12 months. The primary objective is to assess the immediate intraoperative clinical benefits of using TTFM and HFUS during peripheral bypass surgery in patients with CLTI. A key secondary objective is to determine the prognostic value of TTFM and HFUS in predicting one-year clinical outcomes, specifically identifying patients at high risk of graft failure.
Clinical Need and Current Landscape
Peripheral artery disease (PAD) affects over 200 million people worldwide. When PAD progresses to CLTI, patients require immediate revascularization to minimize the risk of limb amputation and cerebrovascular and cardiovascular complications. Peripheral bypass surgery is a common treatment option, with over 500,000 such procedures performed annually. While some surgeons already use TTFM and ultrasound for intraoperative completion control, the PATENT study seeks to provide more robust evidence supporting their widespread adoption.
Technology and Potential Impact
Medistim's technology offers a comprehensive, reliable, and user-friendly alternative to traditional methods like Doppler ultrasound and angiography. The company anticipates that positive results from the PATENT study will drive adoption of their MiraQ devices. Kari E. Krogstad, President and CEO of Medistim, stated, "This study has the potential to be a game-changer for Medistim, much like how the REQUEST study was transformative for the adoption of HFUS in CABG surgery."
Expert Commentary
The study will be led by Professor Michael Conte of the University of California, San Francisco, who is the lead author of the Global Guidelines on the Management of CLTI. "I was intrigued by the solid experience and compelling data collected at the University of Helsinki, which demonstrated a clear correlation between graft flow values and graft failure," said Professor Conte. "I believe the PATENT clinical trial has the potential to becoming a landmark study with impact on clinical practice, to the benefit of CLTI patients worldwide."
Medistim anticipates study-related costs of approximately MNOK 25, spread over a period of 3-4 years. The return on investment is tied to the anticipated ability to demonstrate improved clinical outcomes through the use of TTFM and HFUS, enhancing competitiveness compared to existing technologies.
