Actively Recruiting
MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization
Led by John Paul II Hospital, Krakow · Updated on 2022-03-29
550
Participants Needed
1
Research Sites
560 weeks
Total Duration
On this page
Sponsors
J
John Paul II Hospital, Krakow
Lead Sponsor
J
Jagiellonian University
Collaborating Sponsor
AI-Summary
What this Trial Is About
All-comer study of unselected patients suitable for carotid artery revascularization to evaluate the feasibility, efficacy and safety of first line endovascular revasculariztion using MicroNet covered stent (CGuard™) in the treatment of consecutive symptomatic and increased-stroke-risk asymptomatic carotid lesions that require revascularization by Neurovascular Team decision.
CONDITIONS
Official Title
MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is older than 18 years and qualified by Neurovascular Team for carotid revascularization
- Signed informed consent provided
- Agreement to clinical and ultrasound follow-up
- Presence of new or recurring atherosclerotic lesions
- Symptomatic patients with history of transient ischemic attack, ischemic stroke, or amaurosis fugax within 6 months and artery narrowing 50% or more by angiography
- Asymptomatic patients with artery narrowing between 70% and 80% by angiography
You will not qualify if you...
- No agreement from Neurovascular Team on carotid revascularization
- No signed informed consent
- Life expectancy estimated less than 1 year
- Chronic kidney failure with serum creatinine above 3.0 mg/dL
- Heart attack within 72 hours before the procedure
- Pregnant women
- Diagnosed blood clotting disorders
- Allergy to contrast media not controlled by medication
- Complete blockage of the target artery
- Stent in common carotid artery protruding into aortic arch
- Anatomical issues preventing stent placement
- Significant narrowing in common carotid artery before target lesion unless treated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Cardiac and Vascular Diseases, The John Paul II Hospital
Krakow, Maloplska, Poland, 31-202
Actively Recruiting
Research Team
P
Piotr Musialek, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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