The aim of this clinical trial is to learn if the resorbable scaffold can be successfully implanted in below-the-knee arteries and help to restore the blood flow in diseased vessels. The main questions which will be addressed in this study are:
* Is the implantation of the scaffold safe and easy?
* Does the scaffold dissolve in a reasonable time period?
* Can the stent help to fix intervention-derived vessel injuries such as dissection or recoil? The scaffold will be implanted in patients with critical limb-threatening ischemia which were initially treated with balloon catheters to restore blood flow and where a vessel segment needs additional stabilisation. The scaffold will be implanted during the normal interventional procedure. All 10 patients enrolled into this study will receive at least one scaffold. There is no control group.
The patients will be monitored for their wellbeing after 30 days as well as after 6 and 12 months. The status of the treated vessels will be examined using a non-invasive ultrasound method.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject at least 18 years of age and provided written informed consent
. RF class 3, 4 or 5
. Subject requires treatment of up to 2 de novo or non-ISR restenotic lesions in BTK arteries
. Female subjects of childbearing potential must have a negative pregnancy test prior to treatment
. Presence of at least one patent (\<50% DS) infrapopliteal vessel that has not been revascularized prior to index procedure
. Presence of elastic recoil or dissection type C-F requiring mechanical support after balloon angioplasty (diameter stenosis \>30% by visual estimate)
. Lesion must be located in the native infrapopliteal vessels with reference vessel diameter of ≥2.5 and 4 mm (investigators assessment)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Total lesion length/vessel length covered by BioFade scaffold should not exceed 27 mm
Exclusion criteria
. Prior amputation to the ipsilateral extremity other than the toe or forefoot or major amputation to the contralateral extremity \<1 year prior index procedure
. Subject has known hypersensitivity or contraindication to device material and its degradants (that cannot be adequately premedicated)
. Subject has known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel/prasugrel/ticagrelor and anti-coagulants
. Subject has known hypersensitivity or allergy to contrast media that cannon be medically managed
. Planned amputation on target leg other than toe or forefoot
. Systemic infection or infection within the target limb and/or immunocompromised
. Endovascular or surgical procedure on the target limb within 30 days prior index procedure (not including diagnostic procedures)
. Myocardial infarction within 30 days prior enrollment