Peripheral Bypass Trial for Completion Control

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06264843

Acronym

PATENT

Enrollment

450

Registered

2024-02-20

Start date

2024-11-14

Completion date

2027-12-31

Last updated

2025-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Limb-Threatening Ischemia

Keywords

CLTI

Brief 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

Interventions

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

Identify and validate intraoperative TTFM and HFUS findings (e.g. threshold values of Mean Graft Flow (MGF), MGF capacity, flow curve pattern, morphological issues)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Primary graft patency rate	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

Countries

United States

Contacts

Primary ContactAnne Waaler

anne.waaler@medistim.com+4790892713

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026