Peripheral Bypass Trial for Completion Control (PATENT)

Medistim

Status

Enrolling

Conditions

Chronic Limb-Threatening Ischemia

Treatments

Device: MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes

Study type

Observational

Funder types

Industry

Identifiers

NCT06264843

724

Details and patient eligibility

About

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

Enrollment

450 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.