Aortic & peripheral vascular diseaseCohort study

Safety and Efficacy of a Novel Micro Net Carotid Stent System

JACC Cardiovasc IntervPublished

  • Single-arm trial
  • prospective
  • multicenter
  • pivotal
  • intention-to-treat
  • independent clinical events committee

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 patients · 24 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

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. JACC Cardiovasc Interv. Published 1 December 2025. doi:10.1016/j.jcin.2025.09.027

Summarised from the published abstract; every number is checked against it