Peripheral Bypass Trial for Completion Control

Chronic Limb-Threatening Ischemia Clinical Trial

— PATENT  

Official title:

Open, Prospective, Multicentre Study Addressing the Immediate Benefits and the Prognostic Value of Intraoperative Completion Control Following Infrainguinal Bypass Surgery in CLTI Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06264843
• Other study ID #: 724
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Ischemia

Intervention

Device:
• Medistim MiraQ system with TTFM and L15 HFUS probes
MiraQ™ 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