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Peripheral Bypass Trial for Completion Control

RecruitingObservational study

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

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

What is being tested

Sponsor: Medistim ASA · Participants: 450 · Started: Nov 14, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06264843

Locations in the U.S.

CaliforniaUniversity of California, San Francisco

Conditions

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.