NCT06264843 Peripheral Bypass Trial for Completion Control
| NCT ID | NCT06264843 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medistim ASA |
| Condition | Chronic Limb-Threatening Ischemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-11-14 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 450 participants in total. It began in 2024-11-14 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06264843 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Limb-Threatening Ischemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06264843 currently recruiting?
Yes, NCT06264843 is actively recruiting participants. Contact the research team at anne.waaler@medistim.com for enrollment information.
Where is the NCT06264843 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06264843 clinical trial?
NCT06264843 is sponsored by Medistim ASA. The trial plans to enroll 450 participants.