Peripheral Bypass Trial for Completion Control

ConditionChronic Limb-Threatening Ischemia

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorMedistim ASA

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Chronic Limb-Threatening Ischemia patients scheduled to undergo a vein bypass with or without arterial inflow reconstruction to a below-knee and above ankle target

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes
Device
Identify and validate intraoperative TTFM and HFUS findings (e.g. threshold values of Mean Graft Flow (MGF), MGF capacity, flow curve pattern, morphological issues)

Treatment groups

450 Participants

are divided into 1 treatment group

Group A: Patency of lower extremity vein bypass grafts1 intervention

Trial outcomes

Primary outcomes

Primary graft patency rate

Freedom from any repeat graft intervention, graft thrombosis, or clinically significant stenosis (\>70% by either Duplex criteria or angiographic imaging) in the bypass

Time frame

at 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medistim ASA

Lead sponsor

Source ClinicalTrials.gov

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