Peripheral Bypass Trial for Completion Control

Not Applicable

Not yet recruiting

• Conditions: Chronic Limb-Threatening Ischemia
• Interventions: Device: MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes

• Registration Number: NCT06264843
• Lead Sponsor: Medistim ASA

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-09
• Last Update Submitted: 2024-02-09
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Study Start: 2024-06
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 450

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patency of lower extremity vein bypass grafts	MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes	Primary patency of lower extremity vein bypass grafts at one year

Primary Outcome Measures

Name	Time	Method
Primary graft patency rate	at 1 year	Freedom from any repeat graft intervention, graft thrombosis, or clinically significant stenosis (\>70% by either Duplex criteria or angiographic imaging) in the bypass

Trial Locations

Locations (1)

University of California; 🇺🇸 San Francisco, California, United States