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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04461717
Study type Observational
Source John Paul II Hospital, Krakow
Contact Piotr Musialek, MD, DPhil
Phone +48126142287
Email p.musialek@szpitaljp2.krakow.pl
Status Recruiting
Phase
Start date February 27, 2020
Completion date February 28, 2021

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