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RecruitingNCT06264843PATENTUpdated Oct 14, 2025

Peripheral Bypass Trial for Completion Control

An observational study in Chronic Limb-Threatening Ischemia, sponsored by Medistim ASA. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-14.

Sponsored by Medistim ASA · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
450
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Chronic Limb-Threatening Ischemia

Keywords

  • CLTI
03

In context

Chronic Limb-Threatening Ischemia

343 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 70 are open to participants now.

This study's planned enrollment of 450 is above the median of 123 across 98 observational studies indexed under Chronic Limb-Threatening Ischemia.

Browse Chronic Limb-Threatening Ischemia studies →

Lead sponsor

Medistim ASA is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
450 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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)

06

What researchers measure

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

    Time frame: at 1 year

07

Study locations

1 of 1 sites recruiting
  • University of California
    San Francisco, California 94143, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06264843
Lead sponsor
Medistim ASA
Responsible party
Sponsor
First posted
Feb 20, 2024
Start date
Nov 14, 2024
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 14, 2025

Study contacts

Anne Waaler
Contact
anne.waaler@medistim.com
+4790892713

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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