CGuard Carotid Stent for Carotid Stenosis
(C-Guardians Trial)
Recruiting in Palo Alto (17 mi)
+17 other locations
PM
CM
Overseen byChris Metzger, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: InspireMD
Must be taking: Dual antiplatelet therapy
Must not be taking: Anticoagulants, Antiplatelets
Disqualifiers: Surgery, CKD, Stroke, Dementia, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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.
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?
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
Trial 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 (Stent)
Trial OverviewThe 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Columbia University Irving Medical CenterNew York, NY
University of FloridaJacksonville, FL
Ascension, St. John HospitalDetroit, MI
Oschner HealthNew Orleans, LA
More Trial Locations
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Who Is Running the Clinical Trial?
InspireMD
Lead Sponsor
Trials
8
Patients 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.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
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.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
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.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Microleakage of various cementing agents for casting ceramics].Weng, WM., Zhang, XY., Zhang, FQ.[2018]
In a 3-year study involving 47 patients and 103 restorations, minimally invasive polymer-infiltrated ceramic network (PICN) inlays and partial coverage restorations (PCRs) demonstrated high survival rates of 97.4% and 95.6%, respectively, indicating their efficacy as dental restorations.
While the restorations showed excellent color match and anatomical form, there were significant increases in marginal discoloration and surface roughness over time, suggesting that while they are effective, ongoing monitoring of their long-term performance is necessary.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Polymer-infiltrated ceramic CAD/CAM inlays and partial coverage restorations: 3-year results of a prospective clinical study over 5 years.Spitznagel, FA., Scholz, KJ., Strub, JR., et al.[2018]
In a study involving 83 IPS Empress restorations placed in 30 subjects, the multistep adhesive resin cement (Syntac with Variolink II) showed significantly better results in color match and inlay integrity after one year compared to the self-adhesive resin cement (RelyX Unicem).
Only one failure occurred in the multistep adhesive group due to marginal enamel chipping, indicating that both types of resin composites are generally safe and effective for luting restorations.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
IPS Empress inlays luted with a self-adhesive resin cement after 1 year.Taschner, M., Frankenberger, R., García-Godoy, F., et al.[2009]
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]