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Stent

CGuard Carotid Stent for Carotid Stenosis (C-Guardians Trial)

N/A
Recruiting
Led By Chris Metzger, MD
Research Sponsored by InspireMD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is diagnosed with carotid artery disease treatable with carotid artery stenting and is considered high risk for carotid endarterectomy (CEA) as evidenced by symptomatic or asymptomatic carotid stenosis and co-morbidity or high anatomical risk for CEA.
Subject is willing and able to take dual antiplatelet therapy for a minimum of 30 days.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1-, 2-, 3-year post-index procedure follow-up
Awards & highlights

C-Guardians Trial Summary

This trial is designed to study the safety and effectiveness of a new stent for people with carotid artery stenosis.

Who is the study for?
This trial is for adults who can consent and follow the study plan, willing to take dual antiplatelet therapy for at least 30 days, have a life expectancy of over 2 years, are not pregnant or planning pregnancy during the study, have mild disability from previous strokes, and are high risk for surgery due to carotid artery disease. Excludes those with severe neurological deficits or conditions affecting assessment, enrolled in conflicting studies, active COVID-19 infection, planned surgeries around the procedure time frame, certain vessel conditions that can't be treated with one stent.Check my eligibility
What is being tested?
The CGuard Carotid Stent System is being tested for safety and effectiveness in treating narrowing of the carotid arteries. The trial includes patients both showing symptoms and asymptomatic but at high risk if they were to undergo traditional surgery. It aims to compare results against established data from other similar procedures.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks associated with stenting include reactions to anesthesia or contrast media used during imaging tests (if pre-treatment doesn't work), bleeding complications especially if there's a history of blood disorders or inability to accept transfusions; potential issues related to known allergies including materials like nitinol and titanium.

C-Guardians Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have carotid artery disease and am at high risk for surgery, but can have stenting.
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I am willing and able to take two blood-thinning medications for at least 30 days.
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I am not pregnant or breastfeeding and do not plan to become pregnant during the study.

C-Guardians Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1-, 2-, 3-year post-index procedure follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1-, 2-, 3-year post-index procedure follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure
Secondary outcome measures
Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure for subjects that adhere to antiplatelet pharmacology.
Composite of Ipsilateral stroke, stent thrombosis, cardiovascular death or other device related clinical events
Incidence of DSMI through discharge, 30 days, 6 months, and yearly follow ups till 3 years
+6 more

C-Guardians Trial Design

1Treatment groups
Experimental Treatment
Group I: CGuard groupExperimental Treatment1 Intervention
Single experimental arm compared vs. objective performace goal

Find a Location

Who is running the clinical trial?

InspireMDLead Sponsor
6 Previous Clinical Trials
1,092 Total Patients Enrolled
Chris Metzger, MDPrincipal InvestigatorBallad Health
1 Previous Clinical Trials
295 Total Patients Enrolled
Piotr Musialek, MD DPhilPrincipal InvestigatorJohn Paul II Hospital, Krakow, Poland

Media Library

CGuard Carotid Stent System (Stent) Clinical Trial Eligibility Overview. Trial Name: NCT04900844 — N/A
Carotid Artery Stenosis Research Study Groups: CGuard group
Carotid Artery Stenosis Clinical Trial 2023: CGuard Carotid Stent System Highlights & Side Effects. Trial Name: NCT04900844 — N/A
CGuard Carotid Stent System (Stent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04900844 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants may take part in this experiment?

"This scientific endeavour necessitates the participation of 315 eligible patients, who can register from locations like University of Florida in Jacksonville and Mercy Hospital in Saint Louis."

Answered by AI

Are there multiple Canadian sites conducting this clinical investigation?

"This scientific trial is presently available in 15 different cities, from Jacksonville to Buffalo. It’s suggested that participants pick the closest location so they can minimize their commuting responsibilities."

Answered by AI

Does the research study include participants of all ages, including those over twenty?

"Eligible applicants for this medical trial must lie in the range of 19 to 80 years old. Furthermore, there exist 21 trials designed specifically for those under 18 and 222 studies designated towards individuals aged 65+."

Answered by AI

Are there any recruitment opportunities currently available with this investigation?

"Per clinicaltrials.gov, this medical experiment is currently accepting participants. This research was first introduced on July 1st 2021 and the last update was issued on June 16th 2022."

Answered by AI

Who has the qualifications to take part in this clinical exploration?

"This clinical trial is taking in 315 patients aged between 19 and 80, all of which suffer from carotid artery stenosis. Participants must be willing to take dual antiplatelet therapy for a minimum of 30 days and have life expectancy exceeding 24 months from the index procedure date. Furthermore, female participants cannot become pregnant during the course of the study or breastfeed their infants. Symptomatic subjects are those who experienced amaurosis fugax, TIA (transient ischemic attack), or stroke within 6 months preceding enrollment while asymptomatic ones need an arterial obstruction level that exceeds 80%. Finally, elderly individuals over 70"

Answered by AI
~86 spots leftby Mar 2025