Overview
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.
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 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.
Eligibility
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)