Peripheral Arterial Disease Clinical Trial
Official title:
Promus PREMIER Below The Knee Registry
The Promus Premier below-the-knee (BTK) drug-eluting stent (DES) is specifically designed to improve BTK vessel patency rates using a platinum-chromium alloy based stent that elutes the anti-restenotic drug everolimus to inhibit neo-intimal hyperplasia. Although DES stents are considered standard of care for certain BTK lesions, there is a paucity of data on the use of DES in the contemporary BTK chronic limb threatening ischemia (CLTI) population, especially in Singapore. The aim of the Promus PREMIER BTK registry is to collect one year data of the Boston Scientific Promus PREMIER BTK DES in BTK lesions in CLTI patients.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | August 2023 |
Est. primary completion date | February 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Singapore | Sengkang General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Sengkang General Hospital |
Singapore,
Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, Deloose K, Schmidt A, Tessarek J, Vinck E, Schwartz LB. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012 Feb;55(2):390-8. doi: 10.1016/j.jvs.2011.07.099. Epub 2011 Dec 14. — View Citation
Ipema J, Huizing E, Schreve MA, de Vries JPM, Ünlü Ç. Editor's Choice - Drug Coated Balloon Angioplasty vs. Standard Percutaneous Transluminal Angioplasty in Below the Knee Peripheral Arterial Disease: A Systematic Review and Meta-Analysis. Eur J Vasc Endovasc Surg. 2020 Feb;59(2):265-275. doi: 10.1016/j.ejvs.2019.10.002. Epub 2019 Dec 27. — View Citation
Romiti M, Albers M, Brochado-Neto FC, Durazzo AE, Pereira CA, De Luccia N. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. J Vasc Surg. 2008 May;47(5):975-981. doi: 10.1016/j.jvs.2008.01.005. Epub 2008 Apr 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with primary patency at 6 months post-procedure using duplex ultrasound | Primary patency using duplex ultrasound | 6 months | |
Primary | Number of participants with major adverse events (MAE) at 6 months post-procedure | MAE is defined as above ankle amputation in index limb; major re-intervention; and perioperative 30-day mortality | 6 months | |
Secondary | Number of participants with primary and assisted primary patency | Target lesion patency rate measured by duplex ultrasound | 6 and 12 months | |
Secondary | Number of participants with clinically driven target lesion revascularization | Any surgical or percutaneous intervention to the target lesion after the index procedure | 1, 3, 6 and 12 months | |
Secondary | Major amputation rates | Rates of amputation of the lower limb at the ankle level or above | 1, 3, 6 and 12 months | |
Secondary | Subject quality-of-life values by change in EQ-5D | The EQ-5D is a descriptive system of health related quality-of-life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression) each of which can take 1 of 5 responses. The responses record 5 levels of severity (no problems / slight problems / moderate problems / severe problems / extreme problems) within a particular EQ-5D dimension. The levels are assigned a numeric code 1-5 (e.g., 1 = no problem and 5 = extreme problems). Sub score are not applicable. | 1, 3, 6 and 12 months | |
Secondary | Wound assessment | Descriptive characteristic of wound healing will be recorded | 1, 3, 6 and 12 months | |
Secondary | Change in Rutherford classification | Change in Rutherford classification as assessed by investigator | 3, 6 and 12 months | |
Secondary | Number of adverse events (AEs) | Adverse events (AEs) to be classified as major, serious, non-serious unanticipated, procedure-related, and device-related | 1, 3, 6 and 12 months | |
Secondary | 30-day unplanned hospital readmission rate | Hospitalization related to Critical Limb-Threatening Ischemia (CLTI) | 30-day | |
Secondary | Number of participants with all-cause mortality | Telephone follow-up visit and/or medical chart review and/or publicly available records consultation for vital status | 6 and 12 months | |
Secondary | Change in hemodynamic outcomes | Change in ankle brachial index (ABI) and/or Toe pressure (TP) | 6 and 12 months |
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