MedTrace Logo

Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting

NCT04900844 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2025-04-04

No results posted yet for this study

Summary

The objective of this pivotal study is to evaluate the safety and efficacy of the CGuard™ Carotid Stent System in the treatment of carotid artery stenosis in symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS) to a performance goal developed from published CAS literature.

Conditions

  • Carotid Artery Stenosis

Interventions

DEVICE

CGuard Carotid Stent implantation

Implantation of CGuard carotid stent in the eligible patients

Sponsors & Collaborators

  • InspireMD

    lead INDUSTRY

Principal Investigators

  • Chris Metzger, MD · Ballad Health

  • Piotr Musialek, MD DPhil · John Paul II Hospital, Krakow, Poland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-07-01
Completion
2025-10-01
FDA Device
Yes

Countries

  • United States
  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04900844 on ClinicalTrials.gov