MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization (NCT04271033) | Clinical Trial Compass
RecruitingNot Applicable
MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization
Poland550 participantsStarted 2015-09-01
Plain-language 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 stent (CGuard™) in the treatment of consecutive symptomatic and increased-stroke-risk asymptomatic carotid lesions that require revascularization by Neurovascular Team decision.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
General Inclusion Criteria:
* 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 Inclusion Criteria:
* 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 Criteria:
* 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 Exclusion Criteria:
* Index lesion occlusion
* Common carotid artery stent protruding to aortic arch
* Anatomical conditions restricting stent implantation
* Significant common carotid artery stenosis proximal to index lesion (unless treated)
What they're measuring
1
MACNE (Major Adverse Cardiac and Neurological Events)