Peripheral Vascular Diseases Clinical Trial
Official title:
Prospective Observational Study of Procedures With MicroNet Covered Stent Use to Treat Increased Risk Lesions in Arterial Locations Beyond the Carotid Bifurcation - FLOW-Guard Study
Prospective observational study of MicroNet covered stent implantation in the elevated risk
peripheral lesions (high lesion load, thrombus containing, highly calcified).
Open-label, non randomized, single arm observational study. Jagiellonian University Medical
College research project.
Peripheral artery stents in routine use (both balloon expandable and self-expendable) do not
sufficiently prevent distal embolization. They might induce a "cheese-grater" effect - a
consequence of their single layer design with uncovered space between stent struts.
Aim of the study is to evaluate short and long term safety and efficacy of MicroNet covered
stent implantation in the high risk lesions beyond the carotid bifurcation. Treatment
eligibility will be evaluated by a Vascular Team process (angiologist, vascular surgeon,
cardiologist). Optimal pharmacotherapy will be administered according to the current
guidelines.
Symptomatic and asymptomatic patients with peripheral artery disease requiring endovascular
treatment for high risk stenosis (soft plaque, highly calcific plaque) per Vascular Team
assessment.
A group of 30-50 consecutive patients meeting inclusion and exclusion criteria will be
enrolled.
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