Aortic & peripheral vascular disease
Safety and Efficacy of a Novel Micro Net Carotid Stent System: Results of the C-GUARDIANS Trial
Authors' conclusion
The C-GUARDIAN trial demonstrated low rates of DSMI through 30 days, and ipsilateral stroke through 1 year.
Study context
- Population
- Patients with asymptomatic ≥80% or symptomatic ≥50% carotid stenosis at high risk for carotid endarterectomy, 24 sites in the US and EU, 2021–2023
- Participants
- 316 patients24 sites
- Outcome
- Composite of:
- Death
- All stroke and MI (DSMI) through 30 days postprocedure
- Ipsilateral stroke from 31 to 365 days
- Follow-up
- 1 year
Methodological detailsprospective, multicenter, pivotal, intention-to-treat, independent clinical events committee
- Prospective
- Multicenter
- Pivotal
- Intention-to-treat
- Independent clinical events committee
Main finding
As reported in the abstract
DSMI through 30 days and ipsilateral stroke through 1 year
DSMI at 30 days and ipsilateral stroke at 1 year
1.93%
6/296
Observational data: associations, not effects.
Secondary outcomes
DSMI through 30 days
- DSMI rate through 30 days
- 0.95% (3/316)
Target lesion revascularization · 1 year
- Target lesion revascularization through 1 year
- 1.0% (3/299)
Original publication
Safety and Efficacy of a Novel Micro Net Carotid Stent System: Results of the C-GUARDIANS Trial. JACC Cardiovasc Interv. Published 1 December 2025. doi:10.
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