NCT06264843RecruitingNot Applicable
Open, Prospective, Multicentre Study Addressing the Immediate Benefits and the Prognostic Value of Intraoperative Completion Control Following Infrainguinal Bypass Surgery in CLTI Patients
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Medistim ASA
- Enrollment
- 450
- Locations
- 2
- Primary Endpoint
- Primary graft patency rate
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •CLTI as defined by presence of 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 BTK 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.
Arms & Interventions
Patency of lower extremity vein bypass grafts
Primary patency of lower extremity vein bypass grafts at one year
Intervention: MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes (Device)
Outcomes
Primary Outcomes
Primary graft patency rate
Time Frame: at 1 year
Freedom from any repeat graft intervention, graft thrombosis, or clinically significant stenosis (\>70% by either Duplex criteria or angiographic imaging) in the bypass
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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