Peripheral Bypass Trial for Completion Control
ConditionChronic Limb-Threatening Ischemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedistim ASA
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes
Treatment groups
450 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov