Arterial Disease, Arterial Disease of Legs, Peripheral Arterial Disease
Conditions
Keywords
PVD, BTK, DES, PAD, Everolimus
Brief summary
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.
Detailed description
Peripheral arterial disease (PAD) is an atherosclerotic condition in which chronic inflammation of the arteries may result in CLTI and ultimately limb loss without treatment. This problem is likely to worsen with the increasing global prevalence of diabetes. The arterial blockage for diabetic CLTI patients occur predominantly in the BTK arteries which are challenging to treat effectively due to the high incidence of elastic recoil and high stenosis rates after plain old balloon angioplasty (POBA) of these often calcified lesions. The additional use of BTK drug-coated balloons (DCBs) have also not demonstrated any significant improvements compared to POBA. The Boston Scientific Promus Premier BTK DES is a next generation DES specifically designed to improve BTK vessel patency using a platinum-chromium alloy-based stent that elutes everolimus. It is made with the most radiopaque biocompatible alloy available with superior axial strength, exceptional conformability, maximum fracture resistance, higher radial strength and less recoil compared to cobalt alloy stent. It also has the highest labelled post-dilatation limits compared to other stents, providing clinicians with more flexibility during procedures. Subjects will be followed up at 1 month, 3 month, 6 month and 12 month post-intervention to assess primary and secondary efficacy and safety.
Interventions
DEVICEPromus PREMIER BTK DES
Collect one year data of the Promus PREMIER BTK drug eluting stent in CLTI patients
Sponsors
Sengkang General Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with primary patency at 6 months post-procedure using duplex ultrasound | 6 months | Primary patency using duplex ultrasound |
| Number of participants with major adverse events (MAE) at 6 months post-procedure | 6 months | MAE is defined as above ankle amputation in index limb; major re-intervention; and perioperative 30-day mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with primary and assisted primary patency | 6 and 12 months | Target lesion patency rate measured by duplex ultrasound |
| Subject quality-of-life values by change in EQ-5D | 1, 3, 6 and 12 months | 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. |
| Wound assessment | 1, 3, 6 and 12 months | Descriptive characteristic of wound healing will be recorded |
| Change in Rutherford classification | 3, 6 and 12 months | Change in Rutherford classification as assessed by investigator |
| Number of participants with clinically driven target lesion revascularization | 1, 3, 6 and 12 months | Any surgical or percutaneous intervention to the target lesion after the index procedure |
| 30-day unplanned hospital readmission rate | 30-day | Hospitalization related to Critical Limb-Threatening Ischemia (CLTI) |
| Number of participants with all-cause mortality | 6 and 12 months | Telephone follow-up visit and/or medical chart review and/or publicly available records consultation for vital status |
| Change in hemodynamic outcomes | 6 and 12 months | Change in ankle brachial index (ABI) and/or Toe pressure (TP) |
| Number of adverse events (AEs) | 1, 3, 6 and 12 months | Adverse events (AEs) to be classified as major, serious, non-serious unanticipated, procedure-related, and device-related |
| Major amputation rates | 1, 3, 6 and 12 months | Rates of amputation of the lower limb at the ankle level or above |
Countries
Singapore
Contacts
Primary ContactEdward Choke
Backup ContactEilane Peh
Outcome results
None listed