First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r)

Study Overview
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Brief Summary
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The purpose of this pivotal, first in man study will be to evaluate safety and efficacy of the novel, microcrystalline paclitaxel coated balloon (mcPCB, PAK, Balton) in the treatment of femoropopliteal artery disease.

Detailed Description
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Although clinically effective, the manufacturing process of first generation PCB coatings contributed to inconsistent drug concentrations, particulate formations on the balloon surface and their shedding during the interventional procedures. As a consequence developments of new PCB coatings have been proposed to address consistency, uniformity, small particle drug coverage, which may potentially contribute to improved vessel healing profile and improved clinical outcomes. Nevertheless, data on the safety and efficacy of this novel coating developments in the clinical setting remain limited. Previously in the experimental model, the investigators reported that delivery of paclitaxel via a novel mcPCB resulted in low long-term tissue retention of paclitaxel, however displayed reduced neointimal proliferation and favorable healing profile. Therefore in current clinical trial the investigators will address the feasibility and safety of the mcPCB (PAK, Balton) in the treatment of femoropopliteal restenotic disease in a prospective, randomized manner when compared to plain balloon angioplasty (PBA). The efficacy analysis will be observational and evaluated post-hoc, with no prespecified criteria.

Official Title
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Prospective, Pivotal, First - in Man Clinical Trial of the Safety and Efficacy of a Novel Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease

Conditions
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Peripheral Artery Disease, Femoropopliteal Artery Disease

Intervention / Treatment
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* Drug: Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland)
* Device: Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 y.o. Claudication in Rutherford Class 1-5, Lesion in the femoropopliteal artery defined as >50% and < 99% diameter stenosis with length of up to 10 cm in vessel diameter of 3-7 mm Chronic total occlusions of length less than 100 mm Ability to cross the lesions with a guidewire. Exclusion Criteria: Critical acute or chronic limb ischemia Acute coronary syndrome Chronic kidney disease stage III-V Restenotic lesion Femoropopliteal graft Known allergy to clopidogrel or aspirin History of stroke within past 6 months Age > 80 y.o. Life expectancy < 2 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plain Balloon Angioplasty<br>Plain Balloon Angioplasty | Device: Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland)<br> <br> |
| Experimental: microcrystalline Paclitaxel Coated Balloon (PAK)<br>plain balloon angioplasty followed by mcPCB dilation | Drug: Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic late lumen loss |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Device related adverse events |  | 30 days, 6 months | 
| Critical limb ischemia |  | 30 days, 6 months | 
| Device Success | Successful delivery and deployment of the first inserted study device (in overlapping setting a successful delivery and deployment of the first and second study device) at the intended target lesion and successful withdrawal of the study device with attainment of final residual stenosis of less than 30% of the target lesion by quantitative vessel angiography (QVA). | at procedure | 
| Target Lesion Revascularization |  | 6, 12, 24 months | 
| Target vessel revascularization |  | 6, 12, 24 months | 
| Primary patency of treated segment |  | 6, 12, 24 months | 
| Treated limb amputation |  | 30 days, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paclitaxel coated balloon, restenosis, Femoropopliteal artery disease