CGuard Carotid Stent for Carotid Stenosis

(C-Guardians Trial)

Not currently recruiting at 19 trial locations

Overseen By Christina Brennan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: InspireMD

Must be taking: Dual antiplatelet therapy

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Surgery, CKD, Stroke, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the CGuard Carotid Stent System to evaluate its safety and effectiveness in treating carotid artery stenosis, a narrowing of the neck arteries that can lead to strokes. It targets individuals diagnosed with carotid artery disease who are at high risk for surgery. Those who have experienced symptoms like temporary vision loss, mini-strokes, or a full stroke in the past six months may be suitable candidates. The trial aims to compare the stent's performance with other known treatments. As an unphased trial, it provides patients the opportunity to contribute to important research that could enhance future treatment options.

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 prior data suggests that the CGuard Carotid Stent System is safe for treating carotid artery stenosis?

Research has shown that the CGuard Carotid Stent System is generally safe for individuals with narrowing of the carotid arteries. One study found that using the CGuard stent resulted in very few problems affecting the brain and nervous system. Additionally, the chance of the artery narrowing again after stent placement was low after one year.

These results suggest that the treatment is well-tolerated, with few complications reported in patients. Although researchers are still studying long-term safety, the initial data is promising for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The CGuard Carotid Stent System is unique because it features a mesh-covered design aimed at reducing the risk of plaque debris breaking away, which is a common concern with traditional stents. Most current treatments for carotid stenosis, such as other stent systems or carotid endarterectomy, focus on widening the narrowed artery but don't specifically address the risk of embolization, where plaque particles can lead to strokes. Researchers are excited about CGuard because its innovative design not only helps keep the artery open but also adds a layer of protection against future stroke risks, potentially improving patient outcomes significantly.

What evidence suggests that the CGuard Carotid Stent System is effective for carotid stenosis?

Research has shown that the CGuard Carotid Stent System, which participants in this trial will receive, effectively treats carotid artery narrowing. A review of several studies has found it to be safe, with very few neurological problems and a low chance of the artery narrowing again after one year. One study showed excellent results, with a low complication rate of 0.95% within 30 days and 1.93% after one year. The CGuard stent features a unique dual-layer design with a MicroNet™ mesh that helps prevent plaque from escaping and causing strokes. Overall, these findings suggest that the CGuard stent is a promising option for reducing stroke risk in patients with carotid artery narrowing. ^{1 3 6 7 8}

Who Is on the Research Team?

Piotr Musialek, MD

Principal Investigator

John Paul II Hospital, Krakow, Poland

Chris Metzger, MD

Principal Investigator

Ballad Health

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: CGuard group Experimental Treatment 1 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

Who Is Running the Clinical Trial?

InspireMD

Lead Sponsor

Trials

8

Recruited

1,500+

Published Research Related to This Trial

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 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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10890088/

One-Year Outcomes of CGuard Double Mesh Stent in Carotid ... This meta-analysis shows that CAS with CGuard is safe with minimal neurological adverse events and in-stent restenosis rate at 1 year.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04900844

Safety and Efficacy of the CGuard™ Carotid Stent System ... 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 ...

3. vascularnews.com vascularnews.com/cguard-prime-carotid-stent-gains-us-and-european-approvals-for-stroke-prevention/

CGuard Prime carotid stent gains US and European ... ... efficacy of CGuard Prime for treating carotid artery stenosis. CGuard Prime demonstrated the lowest 30-day (0.95%) and one-year (1.93 ...

4. inspiremd.com inspiremd.com/cguard-prime/

CGuard® Prime Explore the layers of carotid stent innovation. CGuard® Prime features a dual-layer design with a finely woven, non-metallic MicroNet™ mesh outer layer and an ...

5. eurointervention.pcronline.com eurointervention.pcronline.com/article/thirty-day-results-from-prospective-multi-specialty-evaluation-of-carotid-artery-stenting-using-the-cguard-micronet-covered-embolic-prevention-system-in-real-world-multicentre-clinical-practice-the-iron-guard-study

Thirty-day results from prospective multi-specialty ... The aim of the present study was to evaluate periprocedural and 30-day outcomes in a prospective series of patients treated with the CGuard Embolic Prevention ...

6. inspiremd.com inspiremd.com/wp-content/uploads/2025/07/Summary-of-Safety-and-Effectiveness-Data.pdf

summary of safety and effectiveness data (ssed) It will evaluate the long-term safety and effectiveness of the CGuard Prime Carotid Stent. System. All 303 remaining subjects active at the end of the 12 ...

7. inspiremd.com inspiremd.com/wp-content/uploads/2025/08/SSCP-CGuard-Prime.pdf

Summary of Safety and Clinical Performance (SSCP) Report The CGuard Prime Carotid Stent System (CGuard Prime or CGuard Prime System) is a sterile, single-use, permanent implant consisting of a mesh ...

8. evtoday.com evtoday.com/news/inspiremds-cguard-prime-carotid-stent-system-approved-by-fda

InspireMD's CGuard Prime Carotid Stent System ... The study enrolled 316 patients at 24 sites in the United States and Europe to evaluate the safety and efficacy of CGuard Prime for treating ...