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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06264843
Other study ID # 724
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date December 2027

Study information

Verified date February 2024
Source Medistim ASA
Contact Anne Waaler
Phone +4790892713
Email anne.waaler@medistim.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 450
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - CLTI as defined by presence of 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 BTK 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


Related Conditions & MeSH terms

  • Chronic Limb-Threatening Ischemia
  • Ischemia

Intervention

Device:
Medistim MiraQ system with TTFM and L15 HFUS probes
MiraQâ„¢ System with TTFM and L15 HFUS probes utilizes ultrasound to visualize blood flow and guide surgeons intraoperatively to successfully plan and accomplish surgical interventions.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medistim ASA

Outcome

Type Measure Description Time frame Safety issue
Primary Primary graft patency rate at 1 year
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