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MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization

MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization

Recruiting
18 years and older
All
Phase N/A

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.

Study details
    CAROTID ARTERY DISEASE
    CAROTID ARTERY DISEASE

NCT04271033

John Paul II Hospital, Krakow

19 February 2024

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