Status:
UNKNOWN
Micronet Covered Stent in in Arterial Locations Beyond the Carotid Bifurcation - FLOW-Guard Study
Lead Sponsor:
John Paul II Hospital, Krakow
Conditions:
Peripheral Vascular Diseases
Eligibility:
All Genders
18+ years
Brief 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, s...
Detailed 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 the...
Eligibility Criteria
Inclusion
- General
- 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
- 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)
Key Trial Info
Start Date :
February 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04461717
Start Date
February 27 2020
End Date
February 28 2021
Last Update
September 2 2020
Active Locations (1)
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1
Department of Cardiac and Vascular Diseases, The John Paul II Hospital
Krakow, Maloplska, Poland, 31-202