Evaluating flow measurement and ultrasound imaging in vein bypass surgery for limb ischemia
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
This study is testing if using special tools to measure blood flow and take pictures of veins can help improve the results of vein bypass surgery for people with serious circulation problems in their legs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medistim ASA Industry-sponsored |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06264843 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify and validate the effectiveness of flow measurement and ultrasound imaging techniques in patients undergoing vein bypass surgery for chronic limb-threatening ischemia. The study will utilize MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes to assess blood flow and vascular health. Participants will be monitored to gather data on the outcomes of their surgeries and the accuracy of these imaging methods.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with chronic limb-threatening ischemia due to atherosclerotic infra-popliteal peripheral artery disease who have suitable vein conduits for bypass.
Not a fit: Patients with non-atherosclerotic lesions or those requiring bypass with artificial conduits will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes and improve the management of patients with chronic limb-threatening ischemia.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving surgical techniques and patient outcomes in vascular surgery.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Francisco, California
- University of California — San Francisco, California, United States (Recruiting)
Study contacts
- Study coordinator: Anne Waaler
- Email: anne.waaler@medistim.com
- Phone: +4790892713
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.