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Clinical Trial 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.


Clinical Trial 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. The multicenter arm of the project has a specific cohort descriptor: PARADIGM-EXTEND MC ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04271033
Study type Interventional
Source John Paul II Hospital, Krakow
Contact Piotr Musialek, MD, PhD
Phone +48126142287
Email p.musialek@szpitaljp2.krakow.pl
Status Recruiting
Phase N/A
Start date September 1, 2015
Completion date June 2026

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