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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-10-31

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.

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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.

Conditions

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Peripheral Artery Disease Femoropopliteal Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Plain Balloon Angioplasty

Group Type ACTIVE_COMPARATOR

Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland)

Intervention Type DEVICE

microcrystalline Paclitaxel Coated Balloon (PAK)

plain balloon angioplasty followed by mcPCB dilation

Group Type EXPERIMENTAL

Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland)

Intervention Type DRUG

Interventions

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Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland)

Intervention Type DRUG

Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland)

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No