317 Participants Needed

CGuard Carotid Stent for Carotid Stenosis

(C-Guardians Trial)

Recruiting at 17 trial locations
CB
Overseen ByChristina Brennan
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: InspireMD
Must be taking: Dual antiplatelet therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to take dual antiplatelet therapy for at least 30 days, but it doesn't specify if you need to stop other medications. It's best to discuss your current medications with the trial team to see if any changes are needed.

What makes the CGuard Carotid Stent System unique for treating carotid stenosis?

The CGuard Carotid Stent System is unique because it uses a MicroNet-covered stent, which is designed to prevent small particles from breaking off and causing a stroke during the procedure. This is different from other stents that may not have this protective feature.12345

What is the purpose of this trial?

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.

Research Team

PM

Piotr Musialek, MD

Principal Investigator

John Paul II Hospital, Krakow, Poland

CM

Chris Metzger, MD

Principal Investigator

Ballad Health

Eligibility Criteria

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.

Inclusion Criteria

Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
I have carotid artery disease and am at high risk for surgery, but can have stenting.
You are expected to live for at least 24 months from the start of the study.
See 4 more

Exclusion Criteria

I have had a stroke caused by something other than narrowed arteries in my neck within the last year.
My blood vessels cannot safely support certain medical procedures.
The blood vessel being studied is completely blocked.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo carotid artery stenting using the CGuard™ Carotid Stent System

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of ipsilateral stroke and other adverse events

3 years
Regular follow-ups at discharge, 30 days, 6 months, and annually up to 3 years

Treatment Details

Interventions

  • CGuard Carotid Stent System
Trial Overview 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: CGuard groupExperimental Treatment1 Intervention
Single experimental arm compared vs. objective performace goal

CGuard Carotid Stent System is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as CGuard Carotid Stent System for:
  • Carotid artery stenosis in symptomatic and asymptomatic patients
🇺🇸
Approved in United States as CGuard Carotid Stent System for:
  • Investigational device exemption (IDE) for carotid artery stenosis in symptomatic and asymptomatic patients

Find a Clinic Near You

Who Is Running the Clinical Trial?

InspireMD

Lead Sponsor

Trials
8
Recruited
1,500+

Findings from Research

In a study involving 60 extracted human premolars, three different resin-based composite systems were tested for their ability to seal the gingival margin of Class II restorations, revealing that all systems showed some leakage.
The ALERT composite demonstrated significantly less microleakage compared to SureFil and Solitaire, indicating it may be a more effective option for sealing in dental restorations.
Microleakage and adaptation of Class II packable resin-based composites using incremental or bulk filling techniques.Gallo, JR., Bates, ML., Burgess, JO.[2015]
In a study involving 54 patients undergoing carotid artery stenting with the FiberNet distal filter system, the procedure was technically successful for all participants, indicating high feasibility.
The FiberNet system demonstrated a low rate of complications, with only 5.5% experiencing transient ischemic attacks (TIAs) and no major strokes or deaths, suggesting its safety is comparable to conventional filters.
FiberNet--a new embolic protection device for carotid artery stenting.Bauer, C., Franke, J., Bertog, SC., et al.[2019]
In a study involving 16 healthy human molars, both Variolink 2 and RelyX Unicem composite resin cements showed similar effectiveness in sealing microleakage for IPS Empress 2 ceramics after thermal cycling.
Enamel margins had significantly lower microleakage compared to dentin margins, indicating that the type of tooth structure affects the sealing ability of the cement used.
[Microleakage of various cementing agents for casting ceramics].Weng, WM., Zhang, XY., Zhang, FQ.[2018]

References

Microleakage and adaptation of Class II packable resin-based composites using incremental or bulk filling techniques. [2015]
FiberNet--a new embolic protection device for carotid artery stenting. [2019]
[Microleakage of various cementing agents for casting ceramics]. [2018]
Polymer-infiltrated ceramic CAD/CAM inlays and partial coverage restorations: 3-year results of a prospective clinical study over 5 years. [2018]
IPS Empress inlays luted with a self-adhesive resin cement after 1 year. [2009]
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