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Peripheral Bypass Trial for Completion Control

Peripheral Bypass Trial for Completion Control

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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.

Study details
    Chronic Limb-Threatening Ischemia

NCT06264843

Medistim ASA

12 September 2025

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