Recruiting

Peripheral Bypass

Sponsor:

Medistim ASA

Code:

NCT06264843

Conditions

Chronic Limb-Threatening Ischemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06264843

Start date

Nov 14, 2024

Status verified date

Oct, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

Patency of lower extremity vein bypass grafts

Primary patency of lower extremity vein bypass grafts at one year

Interventions

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)

Primary outcome measure

  • Primary graft patency rate [ Time Frame: at 1 year ]

Central Contacts and Locations

Central contacts

Anne Waaler

+4790892713anne.waaler@medistim.com

Locations

University of California

Recruiting

San Francisco, California, United States, 94143

Contacts

Michael Conte, MD

415-353-2256michael.conte2@ucfs.edu

More Information

Sponsor

Medistim ASA

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Keywords

  • CLTI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medistim ASA on 2025-10-14.