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Peripheral Bypass Trial for Completion Control
RecruitingObservational study
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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
What is being tested
- MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes (device)
Sponsor: Medistim ASA · Participants: 450 · Started: Nov 14, 2024
Contact the study team
- Anne Waaler · Phone: +4790892713
Official record on ClinicalTrials.gov — NCT06264843
Locations in the U.S.
| California | University of California, San Francisco |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.