ABLUMINUS DES BTK Registry - FIM

Study Overview
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Brief Summary
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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
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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.

Official Title
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ABLUMINUS Below the Knee (BTK) Drug Eluting Stent (DES) Registry (ABLUMINUS BTK) - First in Men

Conditions
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Atherosclerosis, Peripheral Artery Disease, Arterial Disease of Legs

Intervention / Treatment
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* Device: ABLUMINUS DES drug eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 21 years or older and has signed and dated the trial informed consent document (ICD) Subject is willing and able to comply with the trial testing, procedures and follow-up schedule 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 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 Occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies). Target lesion(s) must be at least 4cm above the ankle joint Degree of stenosis ≥ 70% by visual angiographic assessment RVD is between 2.5 - 3.75mm Total target lesion length (or series of lesion segments) to be treated is > 200 mm Target lesion(s) is located in an area that may be stented without blocking access to patent main branches Treatment of all above the knee inflow lesion(s) is successful prior to treatment of the target lesion Guidewire has successfully crossed the target lesion(s) Exclusion Criteria: Life expectancy ≤ 1year Stroke ≤ 90 days prior to the procedure date Prior or planned major amputation in the target limb Previous surgery in the target vessel(s) (including prior ipsilateral crural bypass) Previously implanted stent in the target vessel(s) Failed PTA of target lesion/vessel ≤ 60 days prior to the procedure date Heel gangrene Subject has a platelet count ≤ 50 or ≥ 600 X 103/µL ≤ 30 days prior to the procedure date NYHA class IV heart failure Subject has symptomatic coronary artery disease (ie, unstable angina) History of myocardial infarction or thrombolysis ≤ 90 days prior to the procedure date Non-atherosclerotic disease resulting in occlusion (eg, embolism, Buerger's disease, vasculitis) Subject is currently taking Canagliflozin Body Mass Index (BMI) <18 Active septicemia or bacteremia Coagulation disorder, including hypercoagulability Contraindication to anticoagulation or antiplatelet therapy Known allergies to stent or stent components Known allergy to contrast media that cannot be adequately pre-medicated prior to the interventional procedure Known hypersensitivity to heparin Subject is on a high dose of steroids or is on immunosuppressive therapy 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 exclusion criteria Angiographic evidence of intra-arterial acute/subacute thrombus or presence of atheroembolism Treatment required in > 2 target vessels (Note: a target lesion originating in one vessel and extending into another vessel is considered 1 target vessel) Treatment requires the use of alternate therapy in the target vessel(s)/lesion(s), (eg, atherectomy, cutting balloon, re-entry devices, laser, radiation therapy) Aneurysm is present in the target vessel(s) Extremely calcified lesions Failure to obtain <30% residual stenosis in a pre-existing lesion

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABLUMINUS DES<br>ABLUMINUS DES drug eluting stent will be deployed after successful conventional balloon angioplasty. Sirolimus drug dosage on the ABLUMINUS DES drug eluting stent system is determined by Concept Medical to deliver the optimal dose of sirolimus to the abluminal surface of the BTK lesions. | Device: ABLUMINUS DES drug eluting stent<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency using duplex ultrasound at 6 months post-procedure | Number of Primary patency using duplex ultrasound at 6 months post-procedure | at 6 months post-procedure | 
| Major adverse events (MAE) 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) | at 6 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary and assisted primary patency | Target lesion patency rate measured by duplex ultrasound | 6, 12, 24 months post procedure | 
| Clinically driven target lesion revascularization | Number of Clinically-driven target lesion revascularization | 1, 3, 6, 12, 24 months post procedure | 
| Major amputation rates | Rates of amputation of the lower limb at the ankle level or above | 1, 3, 6, 12, 24 months post procedure | 
| Subject quality-of-life values by change in EQ-5D (EuroQol 5 dimension) | 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. | 1, 3, 6 and 12 months post procedure | 
| Wound Assessment | Descriptive characteristics of wound healing will be recorded | 1, 3, 6, 12, 24 months post procedure | 
| Rutherford classification | Change in Rutherford classification as assessed by the investigator | 3, 6, 12, 24 months post procedure | 
| Adverse Events | Number of Adverse events | 1, 3, 6, 12, 24 months post procedure | 
| Unplanned hospital readmission | Unplanned hospital related to Critical Limb Ischemia readmission rate | Up to 30 days post procedure | 
| All Cause Mortality | Number of patients with all-cause death | 6, 12, 24 months years post procedure | 
| Hemodynamic outcomes | Changes in ankle brachial index (ABI) and/or Toe pressures (TP | 6 and 12 months post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sirolimus, PAD, PTA, DES