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

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Piotr Musialek
Send
Updated on 5 August 2020
See if I qualify
stenosis

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.

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.

Details
Condition Vascular Diseases, Vascular Diseases, Peripheral vascular disease, Peripheral vascular disease, Atherosclerosis, Atherosclerosis
Age 18years - 100years
Treatment MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcation
Clinical Study IdentifierNCT04461717
SponsorPiotr Musialek
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

stenosis

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.