Peripheral Bypass Trial for Completion Control (PATENT)

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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Limb-Threatening Ischemia
• Intervention / Treatment: Device: MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes

• Study Type: Observational
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Waaler; Phone Number: +4790892713; Email: anne.waaler@medistim.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California
      • Contact: Michael Conte, MD; Phone Number: 415-353-2256; Email: michael.conte2@ucfs.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patency of lower extremity vein bypass grafts; Primary patency of lower extremity vein bypass grafts at one year	Device: MiraQ 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 1 year

Collaborators and Investigators

• Sponsor: Medistim ASA

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 9, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: CLTI
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease; Pathological Conditions, Signs and Symptoms; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: 724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No