Actively Recruiting
Open, Prospective, Multicentre Study Addressing the Immediate Benefits and Prognostic Value of Intraoperative Completion Control Following Infrainguinal Bypass Surgery in Chronic Limb-Threatening Ischemia Patients
Led by Medistim ASA · Updated on 2025-10-14
450
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with Chronic Limb-Threatening Ischemia (CLTI) who are undergoing vein bypass surgery below the knee and above the ankle. The study aims to identify and confirm how flow measurements and ultrasound images taken during surgery relate to the success of the bypass grafts. This observational trial is sponsored by Medistim ASA and focuses on improving the understanding of intraoperative monitoring techniques in this patient group. Participants will have their vein bypass grafts monitored using a device called MiraQ, which uses Transit-Time Flow Measurement (TTFM) and high-frequency ultrasound (HFUS) probes. These tools help identify specific flow patterns and morphological features during surgery. The study will observe the primary graft patency, meaning how well the graft remains open, at one year after surgery. During the study, participants will undergo the bypass surgery with intraoperative monitoring using the MiraQ device. Follow-up appointments will assess the primary graft patency at one year. Researchers will collect data on flow measurements and ultrasound findings to evaluate their prognostic value. Participants will provide informed consent and attend all scheduled visits during the study period, which extends to the end of 2027.
CONDITIONS
Brief Title
Peripheral Bypass Trial for Completion Control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with Chronic Limb-Threatening Ischemia defined by peripheral artery disease with rest pain, gangrene, or lower limb ulceration lasting more than 2 weeks
- Atherosclerotic infra-popliteal peripheral artery disease
- Adequate distal anastomotic target between knee and ankle with one single run-off
- Availability of autogenous vein conduit confirmed by preoperative vein mapping
- Ability to understand the procedure and willingness to comply with the protocol, attend follow-up appointments, and provide written informed consent
You will not qualify if you...
- Bypass surgery using artificial conduit or cryopreserved allografts
- Bypass for non-atherosclerotic lesions
- Life expectancy less than 2 years
- Psychological, developmental, physical, or emotional disorders interfering with surgery or follow-up
- Any condition judged by the investigator to exclude participation
- Excessive risk for adverse events during open surgery as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo intraoperative assessment using the MiraQ device with Transit-Time Flow Measurement and High Frequency Ultrasound probes during their bypass surgery to evaluate graft flow.
1 visit (in-person)
Duration - 1 year
Participants are monitored to assess the primary patency of their lower extremity vein bypass grafts over one year.
Trial Site Locations
Total: 1 location
1
University of California
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
A
Anne Waaler
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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