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

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.

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