Promus PREMIER Below The Knee Registry

Date de début de l'étude : 16 août 2021

Inclusion Criteria: Clinical inclusion criteria 1. Subject is 21 years or older and has signed and dated the informed consent document (ICD) 2. Subject is willing and able to comply with the study procedures, and follow-up schedule 3. Subject has chronic, symptomatic related lower limb ischemia, determined by Rutherford categories 4 to 6 in the target limb, with wound(s) confined to toes/forefoot 4. Subject is a male or non-pregnant female. If female or child-bearing potential, and if sexually active must be using, or agree to use, a medically acceptable method of birth control as confirmed by the investigator Intraoperative inclusion criteria 1. Stenotic, restenotic or occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies). 2. Target lesion(s) must be at least 4cm above the ankle joint 3. A single target lesion per vessel, in up to 2 vessels, in a single limb 4. Degree of stenosis ≥ 70% by visual angiographic assessment 5. RVD is between 2.5 - 3.75mm 6. Total target lesion length (or series of lesion segments) to be treated is ≤ 140 mm (Note: Lesion segment(s) must be fully covered with up to two DES BTK stents) 7. Target vessel(s) reconstitute(s) at or above the stenting limit zone (4cm above the ankle joint) 8. Target lesion(s) is in an area that may be stented without blocking access to patent main branches 9. Treatment of all above the knee inflow lesion(s) is successful prior to treatment of the target lesion 10. Guidewire has successfully crossed the target lesion(s) Exclusion Criteria: Clinical exclusion criteria 1. Life expectancy ≤ 1year 2. Stroke ≤ 90 days prior to the procedure date 3. Prior or planned major amputation in the target limb 4. Previous surgery in the target vessel(s) (including prior ipsilateral crural bypass) 5. Previously implanted stent in the target vessel(s) 6. Failed PTA of target lesion/vessel ≤ 60 days prior to the procedure date 7. Heel gangrene 8. Subject has a platelet count ≤ 50 or ≥ 600 X 103/µL ≤ 30 days prior to the procedure date 9. NYHA class IV heart failure 10. Subject has symptomatic coronary artery disease (i.e., unstable angina) 11. History of myocardial infarction or thrombolysis ≤ 90 days prior to the procedure date 12. Non-atherosclerotic disease resulting in occlusion (e.g., embolism, Buerger's disease, vasculitis) 13. Subject is currently taking Canagliflozin 14. Body Mass Index (BMI) \<18 15. Active septicaemia or bacteraemia 16. Coagulation disorder, including hypercoagulability 17. Contraindication to anticoagulation or antiplatelet therapy 18. Known allergies to stent or stent components 19. Known allergy to contrast media that cannot be adequately pre-medicated prior to the interventional procedure 20. Known hypersensitivity to heparin 21. Subject is on a high dose of steroids or is on immunosuppressive therapy 22. Subject is currently participating, or plans to participate in, another investigational study that may confound the results of this study Intraoperative exclusion criteria 1. Angiographic evidence of intra-arterial acute/subacute thrombus or presence of atheroembolism 2. Treatment required in \> 2 target vessels (Note: a target lesion originating in one vessel and extending into another vessel is considered 1 target vessel) 3. Treatment requires the use of alternate therapy in the target vessel(s)/lesion(s), (e.g., atherectomy, cutting balloon, re-entry devices, laser, radiation therapy) 4. Aneurysm is present in the target vessel(s) 5. Extremely calcified lesions 6. Failure to obtain \<30% residual stenosis in a pre-existing lesion