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
Conditions
Chronic Limb-Threatening Ischemia
Locations
University of California
San Francisco, California 94143
United States