Status:
RECRUITING
MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization
Lead Sponsor:
John Paul II Hospital, Krakow
Collaborating Sponsors:
Jagiellonian University
Conditions:
Carotid Artery Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Independent investigator initiated, academic, single arm, open-label, non-randomized, prospective, multicenter, multispecialty trial of CGuard™ routine use in all-comer population of consecutive patie...
Eligibility Criteria
Inclusion
- General
- Patient \> 18 years old qualified by NeuroVascular Team for carotid revascularization according to local standards of care
- Signed informed consent
- Agreement (routin un this group of patients) to clinical and ultrasonographis follow up.
- Angiographic
- De-novo atherosclerotic lesions or neo-atherosclerosis
- Symptomatic patients (history of transient ischemic attack, ischaemic stroke or amaurosis fugax within 6 months from index procedure) with index artery stenosis ≥50% assessed in angiography with NASCET method or
- Asymptomatic patients with index artery stenosis ≥70-80% assessed in angiography with NASCET method
- General
Exclusion
- Lack of NeuroVascular Team agreement on carotid revascularization indication
- Lack of signed informed consent
- Estimated life expectancy less than 1 year
- Chronic renal failure with serum creatinine level \> 3.0 mg/dL
- Myocardial Infarction within 72 hours prior to index procedure.
- Pregnant women
- Diagnosed coagulopathies
- History of contrast media allergy, not reacting to pharmacotherapy
- Angiographic
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT04271033
Start Date
September 1 2015
End Date
June 1 2026
Last Update
March 29 2022
Active Locations (1)
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1
Department of Cardiac and Vascular Diseases, The John Paul II Hospital
Krakow, Maloplska, Poland, 31-202