Micronet Covered Stent in in Arterial Locations Beyond the Carotid Bifurcation - FLOW-Guard Study

John Paul II Hospital, Krakow

Status

Unknown

Conditions

Peripheral Vascular Diseases

Treatments

Device: MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcation

Study type

Observational

Funder types

Other

Identifiers

NCT04461717

FLOW-Guard

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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