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NCT06264843Recruiting

Peripheral Bypass Trial for Completion Control

Medistim ASA

Start Date

11/14/2024

Completion Date

12/1/2027

Summary

The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Chronic Limb-Threatening Ischemia as defined by presence of Peripheral Artery Disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration\>2 weeks duration (ref Global Guidelines) * Atherosclerotic infra-popliteal PAD * Adequate distal anastomotic target (crural, tibial or popliteal below the knee with one single run-off) between knee and ankle distal to the stenotic/occluded segment. * Available autogenous vein conduit based on preoperative vein mapping. * Understand the nature of the procedure and willingness to comply with protocol. Attend follow-up appointments and provide written informed consent. Exclusion Criteria: * Bypass with artificial conduit or cryopreserved allografts * Bypass for non-atherosclerotic lesions * Life-expectancy less than 2 years * Any psychological, developmental, physical or emotional disorder that the investigator believes would interfere with surgery or follow-up. * Any condition that the investigator believes should exclude participation. * Excessive risk for adverse events during open surgery as judged by the investigator.

Interventions

DEVICE

MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes

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Conditions

Chronic Limb-Threatening Ischemia

Locations

University of California

San Francisco, California 94143

United States