Study on Intraoperative Flow and Ultrasound Monitoring During Lower Leg Vein Bypass Surgery for Chronic Limb-Threatening Ischemia

What this Trial Is About

Researchers are studying patients with Chronic Limb-Threatening Ischemia CLTI who are undergoing vein bypass surgery below the knee and above the ankle. The study aims to identify and confirm how flow measurements and ultrasound images taken during surgery relate to the success of the bypass grafts. This observational trial is sponsored by Medistim ASA and focuses on improving the understanding of intraoperative monitoring techniques in this patient group. Participants will have their vein bypass grafts monitored using a device called MiraQ, which uses Transit-Time Flow Measurement TTFM and high-frequency ultrasound HFUS probes. These tools help identify specific flow patterns and morphological features during surgery. The study will observe the primary graft patency, meaning how well the graft remains open, at one year after surgery. During the study, participants will undergo the bypass surgery with intraoperative monitoring using the MiraQ device. Follow-up appointments will assess the primary graft patency at one year. Researchers will collect data on flow measurements and ultrasound findings to evaluate their prognostic value. Participants will provide informed consent and attend all scheduled visits during the study period, which extends to the end of 2027.

Peripheral Bypass Trial for Completion Control