Chronic Limb-Threatening Ischemia Clinical Trial
— PATENTOfficial title:
Open, Prospective, Multicentre Study Addressing the Immediate Benefits and the Prognostic Value of Intraoperative Completion Control Following Infrainguinal Bypass Surgery in CLTI Patients
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 |
Verified date | February 2024 |
Source | Medistim ASA |
Contact | Anne Waaler |
Phone | +4790892713 |
anne.waaler[@]medistim.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Medistim ASA |
Type | Measure | Description | Time frame | Safety issue |
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Primary | Primary graft patency rate | at 1 year |
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