MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization
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- STATUS
- Recruiting
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- End date
- Jun 29, 2026
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- participants needed
- 550
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- sponsor
- John Paul II Hospital, Krakow
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.
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.
Details
| Condition | CAROTID ARTERY DISEASE, CAROTID ARTERY DISEASE |
|---|---|
| Age | 18years - 100years |
| Treatment | Carotid artery stenting |
| Clinical Study Identifier | NCT04271033 |
| Sponsor | John Paul II Hospital, Krakow |
| Last Modified on | 19 February 2024 |
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