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Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting - Trial NCT04900844

Access comprehensive clinical trial information for NCT04900844 through Pure Global AI's free database. This phase not specified trial is sponsored by InspireMD and is currently Recruiting. The study focuses on Carotid Artery Stenosis. Target enrollment is 315 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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Trial Details
ClinicalTrials.govNCT04900844
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Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting
A Multicenter, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the CGuard™ Carotid Stent System When Used to Treat Symptomatic and Asymptomatic Carotid Artery Stenosis in Patients Undergoing Carotid Artery Stenting

Study Focus

Carotid Artery Stenosis

CGuard Carotid Stent implantation

Interventional

device

Sponsor & Location

InspireMD

New Orleans,Detroit,Cleveland,Harrisburg,Greenville,Sioux Falls,Kingsport,Knoxville,Austin, United States of America

Timeline & Enrollment

N/A

Jul 01, 2021

Oct 01, 2025

315 participants

Primary Outcome

Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure

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.

ICD-10 Classifications

Occlusion and stenosis of carotid artery
Carotid artery syndrome (hemispheric)
Injury of carotid artery
Aneurysm and dissection of carotid artery
Occlusion and stenosis of vertebral artery

Data Source

ClinicalTrials.gov

NCT04900844

Device Trial