Peripheral Bypass Trial for Completion Control

NCT06264843 | Recruiting FDA Device

• 1 other identifier: 724
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Limb-Threatening Ischemia

Keywords

CLTI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

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)

Patency of lower extremity vein bypass grafts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medistim ASA: lead

Study Sites (1)

University of California

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Anne Waaler

CONTACT

+4790892713; anne.waaler@medistim.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)