Overview
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.
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.
Eligibility
General
Inclusion Criteria:
- Patients older than 18 years, eligible for peripheral artery stenting after Vascular Team evaluation, according to local standards
- Written, informed consent to participate
- Agreement to attend protocol required (standard) follow up visits and examinations
Exclusion Criteria:
- Life expectancy <1 year (e.g. active neoplastic disease).
- Chronic kidney disease with creatinine > 3.0 mg/dL.
- Myocardial infarction in 72 hours proceeding the stenting procedure (if possible, postponing the procedure)
- Pregnancy (positive pregnancy test)
- Coagulopathy.
- History of uncontrolled contrast media intolerance
Angiographic
Inclusion Criteria:
- De novo lesion in major arteries or grafts connecting arteries
- Stenosis eligible for endovascular treatment per Vascular Team evaluation (according to current standards and guidelines)
- High risk morphology stenosis (per 2 independent, experienced operators)
Exclusion Criteria:
- Chronic total occlusion not amenable to re-canalization
- Stent in the target vessel/lesion
- Anatomic variants precluding stent implantation
- Mobile (free-floating) plaque elements in aorta or arteries proximal to target lesion