MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization
MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization
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.
Independent investigator initiated, academic, single arm, open-label, non-randomized,
 prospective, multicenter, multispecialty trial of CGuard™ routine use in all-comer population
 of consecutive patients with symptomatic or increased-stroke-risk asymptomatic carotid
 stenosis.

 Increased-stroke-risk is defined as the following patient and/or lesion characteristics:

 thrombus containing, documented progressive, irregular, ulcerated lesion; evidence of
 ipsilateral ischemic cerebral injury in MRI or CT imaging; contralateral stroke in relation
 to carotid stenosis; contralateral artery occlusion.

 The main objective of this observational study is to evaluate (1) the periprocedural
 feasibility and efficacy of CGuard™ stent system in the treatment of carotid artery stenosis
 (2) long-term efficacy and safety of routine CGuard™ stent system use.

 The study hypothesis is that the novel CGuard™ MicroNet® covered stent is safe and effective
 for a majority of consecutive patients considered to require carotid revascularization.
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)