The VaSecure BTK Study

Study Overview
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Brief Summary
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To assess the safety and performance of the VaSecure drug-coated PTA balloon catheter in the treatment of patients with Chronic Limb Threatening Ischemia (CLTI) of the lower limb below the knee (BTK)

Detailed Description
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The VaSecure Drug Coated PTA Balloon Catheter is indicated for percutaneous transluminal angioplasty (PTA), after predilatation, of de novo lesions in the peripheral vasculature of the lower limb with reference vessel diameters of 2-4 mm. The study will include patients with lesions located in the infrapopliteal arteries diagnosed with CLTI of Rutherford categories 3-5. A maximum number of 46 patients will be enrolled in this clinical investigation in 7 sites in Europe and 2 in Singapore.

Official Title
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Clinical Investigation of the Safety & Effectiveness of the VaSecure 018 Drug Coated PTA Balloon Catheter in the Treatment of Patients With Chronic Limb Threatening Ischemia (CLTI) Involving Below-the-Knee (BTK) Arteries

Conditions
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Peripheral Artery Disease, Peripheral Vascular Disease, Peripheral Arterial Occlusive Disease

Intervention / Treatment
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* Device: VaSecure™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide written informed consent prior to participating in the clinical investigation, e.g. patients are mentally able to understand the aim of the clinical investigation. Has a documented diagnosis of CLTI of Rutherford category 3-5. The target lesion must be de novo. Life expectancy is >1 year, in the investigator's opinion. For women: menopausal or under active birth control. Patient must agree not to participate in any other clinical trial during 12 month follow-up period. Visual angiographic inclusion criteria Reference vessel(s) diameter is between 2mm-4mm. Each lesion in one or maximum two of the infrapopliteal arteries NOT extending beyond the ankle joint. Target lesion(s) consisting of a single solitary or series of multiple adjacent lesions (all less than 30 mm apart) in a single tibial vessel with a diameter stenosis ≥70% and a cumulative length of ≥50 mm to ≤250 mm. If there are two target lesions they will be separated for ≥3 cm and will be named from proximal to distal. Target lesion must be a tibial vessel (excluding popliteal artery) branching from popliteal artery. Exclusion Criteria: Breastfeeding or pregnant woman. Severe concentric calcification, documented by angiography using the COMPLIANCE360-Score (This scoring system takes into account both the arc of calcium (< or > 180º) and percent of lesion length (< or > 50%) as judged by fluoroscopy.) that could not be fully expanded by predilatation balloon and documented by angiography. Valid record up to 30 days before screening. Patients with major amputations that have already been performed or are planned, either on the target leg or on the contralateral side. . History of stroke within 3 months. History of myocardial infarction, thrombolysis or angina within 30 days prior to index procedure. Renal failure or chronic kidney disease with estimated Glomerular Filtration Rate (eGFR) ≤30 mL/min per 1.73 m2 (or serum creatinine ≥2.5 mg/dL within 30 days of index procedure or treated with dialysis). Diagnosed active untreated systemic infection or uncontrolled coagulopathy within 14 days prior to index procedure. Co-morbid conditions limiting life expectancy to <12 months. Hemorrhagic diathesis or another disorder such as gastrointestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anticoagulation therapy. Known allergy to paclitaxel or paclitaxel-related compounds or contrast media that cannot be adequately managed with pre- and post-procedure medication. Is currently participating in an investigational drug or other investigational device study or previously enrolled in this study. Is unlikely to comply with the follow up schedule. Has uncontrolled ulcer wound infection. Is unwilling to comply with a concurrent ulcer wound therapy. Has an allergy to acetylsalicylic acid, prasugrel, ticagrelol, and clopidogrel (Plavix®). Use of atherectomy in proximal vessels or TL. However, the use of scoring/cutting balloons in the TL is allowed. Angiographic exclusion criteria Lesions that cannot be successfully predilated to achieve a residual stenosis of <50% by visual estimate. Severe dissection post dilatation resulting in a flow limiting lesion. Thrombus in the target vessel documented by angiography. Aneurysm in the target vessel(s). Treatment of the contralateral limb during the same index procedure or within 30 days post-index procedure in order to avoid confounding complications.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VaSecure™ Drug Coated PTA Balloon Catheter<br> | Device: VaSecure™<br>* Drug Coated PTA Balloon Catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from a composite endpoint of Major adverse limb event (MALE) and procedure-related mortality. | Major adverse limb event is defined as the composite of either major amputation or major re-intervention through 30 days of the index procedure. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure success rate | Composite of technical success defined as successful vascular access and completion of the endovascular procedure as well as immediate morphological success with <30% residual reduction in diameter as assessed by QVA and Device success defined as exact deployment of the device according to the Instructions For Use (IFU) as documented by suitable imaging means | Index procedure or 1 day post index procedure | 
| Incidence of all Adverse Events (AEs) | All AEs will be characterized by severity, relatedness, outcome and treatment | 30 days, and 3, 6, 9 and 12 months | 
| Freedom from major target limb amputation | Rates of amputation of the lower limb above 1 cm from the ankle mortice/joint upwards | 3, 6, 9 and 12 months | 
| Freedom from clinically-driven target lesion revascularization (cd-TLR) and target vessel revascularization (TVR) | Clinically-driven TLR is defined by core lab confirmation of restenosis ≥70% in the target lesion with wound persistence, new wounds or re-occurence of ischemic rest pain | 3, 6, 9 and 12 months | 
| Late Lumen Loss (LLL) of the target lesion | As measured by QVA | 6 months | 
| Angiographic Restenosis | Defined as ≥70% diameter stenosis on 2-view angiography by visual estimate | 6 months | 
| Angiographic Restenotic Burden | Defined as the percentage of length of stenosis/occlusion ≥70% on 2-view angiography by visual estimate in mm, divided by the total length of the lesion in mm | 6 months | 
| Freedom from occlusion (FFO) without cd-TLR on Duplex ultrasound | Defined as presence of flow on colour doppler of the target lesion | 3, 6 and 9 months | 
| Haemodynamic microvascular performance | As measured by transcutaneous oxygen (TcpO2) | Baseline, 3, 6 and 12 months | 
| Haemodynamic microvascular performance | As measured by Ankle-Brachial-Index (ABI). | Baseline, 6 and 12 months | 
| Wound healing rate | Defined as healed or not, if not, improving, stagnant or worsening | 30 days, 3, 6, 9 and 12 months. | 
| Rutherford status | Change in Rutherford classification as assessed by the investigator | 3, 6, 9 and 12 months | 
| Clinical Improvement (combined endpoint) in amputation free, cd-TLR free, surviving patients | Specified as an improvement shift in the Rutherford classification of one class. | 3, 6, 9 and 12 months | 
| Limb salvage | Defined as preservation of a functional foot without the need for a leg prosthesis | 6 and 12 months | 
| Amputation-free survival | Defined as composite endpoint of mortality and amputation | 6 and 12 months |