MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization (PARADIGM-EXT)
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- STATUS
- Recruiting
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- End date
- Jun 24, 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.
The multicenter arm of the project has a specific cohort descriptor: PARADIGM-EXTEND MC
Details
| Condition | Carotid Artery Diseases |
|---|---|
| Treatment | Carotid Artery Stenting |
| Clinical Study Identifier | NCT04271033 |
| Sponsor | John Paul II Hospital, Krakow |
| Last Modified on | 24 April 2022 |
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