Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around

Description

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

Official Title

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

Keywords

Chronic Limb-Threatening Ischemia, CLTI, Ischemia, MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes, Patency of lower extremity vein bypass grafts

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Location

  • University of California accepting new patients
    San Francisco California 94143 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medistim ASA
ID
NCT06264843
Study Type
Observational
Participants
Expecting 450 study participants
Last Updated