CLTI Defined as Rutherford Category 4 or 5, PAOD (Peripheral Arterial Obstructive Disease)
Conditions
Brief summary
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.
Interventions
DEVICEPTA
Following the verification of all inclusion and exclusion criteria, the BioFade scaffold is delivered to the treatment site and will be deployed.
Sponsors
MeKo Manufacturing e.K.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient related 1. Subject at least 18 years of age and provided written informed consent 2. RF class 3, 4 or 5 3. Subject requires treatment of up to 2 de novo or non-ISR restenotic lesions in BTK arteries 4. Female subjects of childbearing potential must have a negative pregnancy test prior to treatment 5. Presence of at least one patent (\<50% DS) infrapopliteal vessel that has not been revascularized prior to index procedure Lesion related 6. Presence of elastic recoil or dissection type C-F requiring mechanical support after balloon angioplasty (diameter stenosis \>30% by visual estimate) 7. Lesion must be located in the native infrapopliteal vessels with reference vessel diameter of ≥2.5 and 4 mm (investigators assessment) 8. Total lesion length/vessel length covered by BioFade scaffold should not exceed 27 mm 9. Significant lesion (≥ 50% stenosis) in the inflow artery(ies) must be treated successfully (as per physician's assessment) through standard of care prior to the treatment of the target lesion. Treatment can be done within the same trial procedure. 10. Distal margin of lesion must be located ≥10 cm above the proximal margin of the ankle mortise 11. Non-target lesion, if any, must be located in separate infrapopliteal arteries and suitable to be treated per standard of care using PTA
Exclusion criteria
Patient related 1. Prior amputation to the ipsilateral extremity other than the toe or forefoot or major amputation to the contralateral extremity \<1 year prior index procedure 2. Subject has known hypersensitivity or contraindication to device material and its degradants (that cannot be adequately premedicated) 3. Subject has known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel/prasugrel/ticagrelor and anti-coagulants 4. Subject has known hypersensitivity or allergy to contrast media that cannon be medically managed 5. Planned amputation on target leg other than toe or forefoot 6. Systemic infection or infection within the target limb and/or immunocompromised 7. Endovascular or surgical procedure on the target limb within 30 days prior index procedure (not including diagnostic procedures) 8. Myocardial infarction within 30 days prior enrollment 9. History of stroke within 90 days prior enrollment 10. Patient is currently participating in another clinical study whose requirements conflict with or affect this clinical investigation 11. Presence of any conditions that, in the investigator's opinion, could limit the participants ability to comply with the follow-up requirements, or impact the scientific soundness of the clinical investigation results 12. Patient has subacute limb ischemia which requires thrombolysis as a treatment modality 13. Patient has acute limb ischemia of the target limb 14. Patient is bedridden or unable to walk (assistance is acceptable) 15. Pregnant females or females of child-bearing potential without negative result of pregnancy test Lesion related 16. In-stent restenosis (metallic stent) 17. Severe calcification (calcification renders the target lesion non-dilatable or has ≥5 cm of circumferential calcification) 18. Evidence of thrombus in target vessel 19. Evidence of thromboembolism or atheroembolism in the study leg 20. No angiographic evidence of a patent pedal artery 21. Aneurysm at treatment location 22. Lesions/dissections exceeding 27 mm 23. Visual hint of an additional significant stenosis (≥50%) in the target vessel prior index procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety endpoint | day 30 | Freedom from device and procedure related events (thrombosis, embolization, amputation, device-related death, target lesion reintervention) at 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy endpoint | day 1 | Device success |
Countries
Uzbekistan
Outcome results
None listed