Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGOBSERVATIONAL

Peripheral Bypass Trial for Completion Control

Open, Prospective, Multicentre Study Addressing the Immediate Benefits and the Prognostic Value of Intraoperative Completion Control Following Infrainguinal Bypass Surgery in Chronic Limb-Threatening Ischemia (CLTI) Patients

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

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

Identify and validate intraoperative TTFM and HFUS findings (e.g. threshold values of Mean Graft Flow (MGF), MGF capacity, flow curve pattern, morphological issues)

Locations (1)

University of California
San Francisco, California, United States