Femoropopliteal Artery Disease, Peripheral Artery Disease
Conditions
Keywords
paclitaxel coated balloon, restenosis, Femoropopliteal artery disease
Brief summary
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
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.
Interventions
DRUGLocal drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland)
DEVICEPlain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland)
Sponsors
American Heart of Poland
Balton Sp.zo.o.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Angiographic late lumen loss | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | at procedure | 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). |
| Target vessel revascularization | 6, 12, 24 months | — |
| Primary patency of treated segment | 6, 12, 24 months | — |
| Treated limb amputation | 30 days, 6 months | — |
| Safety - Device related adverse events | 30 days, 6 months | — |
| Critical limb ischemia | 30 days, 6 months | — |
| Target Lesion Revascularization | 6, 12, 24 months | — |
Other
| Measure | Time frame |
|---|---|
| Flow velocity in doppler ultrasonography | 3, 6 and 12 months |
| Change in ankle-brachial index | pre-procedure, 3,6 and 12 months |
| Change in Walking Impairment Questionnaire (WIQ) | pre procedure, 3, 6 and 12 months |
Countries
Poland
Outcome results
None listed