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
Medistim ASA
450 participants
Nov 14, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria6
- 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.
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Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT06264843