Evaluating flow measurement and ultrasound imaging in vein bypass surgery for limb ischemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of California
  San Francisco, California, United States Recruiting

Study contacts

• Study coordinator: Anne Waaler
• Email: anne.waaler@medistim.com
• Phone: +4790892713

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Esprit BTK everolimus-eluting resorbable scaffold in infrapopliteal artery disease for CLTI

  This study tests whether the Esprit BTK Everolimus Eluting Resorbable Scaffold works in real-world patients with chronic limb-threatening ischemia and heavily calcified infrapopliteal arteries.

  Recruiting Cardiovascular and Interventional Radiological Society of Europe · Hull · NCT07270575

• Orbital Atherectomy to Prep Calcified Leg Arteries in CLTI Patients

  This Europe-wide study tests how well orbital atherectomy helps patients with chronic limb-threatening ischemia when opening heavily calcified leg arteries.

  Recruiting Cardiovascular and Interventional Radiological Society of Europe · Hull · NCT07270562

• Predictors of Major Adverse Limb Events After Iliac Artery Stenting

  This study tests what factors predict serious limb-related problems after iliac artery stenting in adults with peripheral artery disease.

  Recruiting I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Milan, Mi · NCT07672249

• Colchicine for people with severe limb-threatening leg artery disease

  A low-dose colchicine pill is being tested to see if it can help people with chronic limb-threatening ischemia avoid worsening of their leg condition and improve outcomes.

  Recruiting at 2 sites Phase 3 Shin Kong Wu Ho-Su Memorial Hospital · Taipei, Taipei and 4 other locations · NCT07536373

• Imaging plaque activity across the body in people with symptomatic peripheral arterial disease

  This project will use whole-body PET-CT and CT angiography with several tracers to see if imaging can detect inflammation, microcalcification, and clot activity in people with symptomatic peripheral arterial disease.

  Recruiting University of Edinburgh · Edinburgh, Midlothian · NCT07472049

• Vessel recoil after below-the-knee revascularization in high-risk CLTI patients

  This study tests how much vessels recoil after a final endovascular treatment in adults with chronic limb-threatening ischemia affecting below-the-knee arteries.

  Recruiting Medical University of Graz · Graz · NCT07465627

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.