Peripheral Bypass Trial for Completion Control

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

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Key information

Conditions

Chronic Limb-Threatening Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Michael Conte, MD

CONTACT

[email protected]

415-353-2256

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

Primary graft patency rate

Time frame: at 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Waaler

CONTACT

[email protected]

+4790892713

Sponsors and collaborators

Lead sponsor

Medistim ASA

Industry

Registry information

Official study 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

Acronym: PATENT

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Feb 20, 2024
Registry last updated: Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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