Arterial Disease of Legs, Atherosclerosis, Peripheral Artery Disease
Conditions
Keywords
Sirolimus, DES, PAD, PTA
Brief summary
A prospective, single center, single arm non-randomized trial collecting safety and effectiveness data for the ABLUMINUS DES System to treat BTK lesions in subjects with CLI.
Detailed description
The burden of limb loss as a result of peripheral arterial disease (PAD) is high and this problem is set to worsen globally with increasing prevalence of diabetes. Treatment of PAD in diabetic critical limb ischemia (CLI) primarily involves revascularisation of the limb. Angioplasty as a first line strategy of revascularization over surgical procedures has been adopted by most vascular centers. Arterial blockages for diabetic CLI patients occur predominantly in below the knee arteries which can be challenging to treat effectively. This is due to the high incidence of arterial recoil after conventional balloon angioplasty due the natural tendency of the vessels to maintain their original shape and the high restenosis rates of calcified lesions. To address these problems the novel ABLUMINUS DES system is specifically designed to withstand the mechanical recoil of diseased BTK arteries whilst delivering sirolimus to biologically inhibit restenosis. This study postulates that the application of the ABLUMINUS DES system will be safe and will result in better vascular patency in BTK arteries for CLI patients. The investigators aim to conduct a prospective, all comers, single arm, single centre registry of the ABLUMINUS DES system for the treatment of BTK disease.
Interventions
DEVICEABLUMINUS DES drug eluting stent
Following successful plain balloon angioplasty of the arterial lesion, (defined as \<30% residual stenosis after treatment at rated burst pressure of the angioplasty balloon), the ABLUMINUS stent will be deployed at the lesion as per Instructions for Use (IFU) after appropriate sizing using the diameter of the plain balloon angioplasty. After deployment of the ABLUMINUS stent, further balloon angioplasty of the stent will be performed, using the same diameter standard balloon catheter at 2 minutes inflation, to ensure adequate moulding and expansion of the stent.
Sponsors
Concept Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
During the index angioplasty revascularisation procedure of the limb salvage programme, the ABLUMINUS DES drug eluting stent will be deployed after successful conventional balloon angioplasty.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is 21 years or older and has signed and dated the trial informed consent document (ICD) 2. Subject is willing and able to comply with the trial testing, procedures and follow-up schedule 3. Subject has chronic, symptomatic diabetic 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 of 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. 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. Degree of stenosis ≥ 70% by visual angiographic assessment 4. RVD is between 2.5 - 3.75mm 5. Total target lesion length (or series of lesion segments) to be treated is \> 200 mm 6. Target lesion(s) is located in an area that may be stented without blocking access to patent main branches 7. Treatment of all above the knee inflow lesion(s) is successful prior to treatment of the target lesion 8. Guidewire has successfully crossed the target lesion(s)
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 (ie, unstable angina) 11. History of myocardial infarction or thrombolysis ≤ 90 days prior to the procedure date 12. Non-atherosclerotic disease resulting in occlusion (eg, embolism, Buerger's disease, vasculitis) 13. Subject is currently taking Canagliflozin 14. Body Mass Index (BMI) \<18 15. Active septicemia or bacteremia 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 trial that may confound the results of this trial (unless written approval is received from the Concept Medical study team) Intraoperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency using duplex ultrasound at 6 months post-procedure | at 6 months post-procedure | Number of Primary patency using duplex ultrasound at 6 months post-procedure |
| Major adverse events (MAE) at 6 months post-procedure | at 6 months post-procedure | Number of Major adverse events (MAE) (MAE is defined as above ankle amputation in index limb; major re-intervention; and perioperative (30 day) mortality) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major amputation rates | 1, 3, 6, 12, 24 months post procedure | Rates of amputation of the lower limb at the ankle level or above |
| Subject quality-of-life values by change in EQ-5D (EuroQol 5 dimension) | 1, 3, 6 and 12 months post procedure | 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 (eg, 1= no problems and 5= extreme problems). Sub-scores are not applicable. |
| Wound Assessment | 1, 3, 6, 12, 24 months post procedure | Descriptive characteristics of wound healing will be recorded |
| Rutherford classification | 3, 6, 12, 24 months post procedure | Change in Rutherford classification as assessed by the investigator |
| Primary and assisted primary patency | 6, 12, 24 months post procedure | Target lesion patency rate measured by duplex ultrasound |
| Unplanned hospital readmission | Up to 30 days post procedure | Unplanned hospital related to Critical Limb Ischemia readmission rate |
| All Cause Mortality | 6, 12, 24 months years post procedure | Number of patients with all-cause death |
| Hemodynamic outcomes | 6 and 12 months post procedure | Changes in ankle brachial index (ABI) and/or Toe pressures (TP |
| Adverse Events | 1, 3, 6, 12, 24 months post procedure | Number of Adverse events |
| Clinically driven target lesion revascularization | 1, 3, 6, 12, 24 months post procedure | Number of Clinically-driven target lesion revascularization |
Countries
Singapore
Contacts
Primary ContactEdward Choke
Backup ContactEdward Choke
Outcome results
None listed