CGuard Prime Carotid Stent for Stroke

Overseen By CARLOS LOUIS PENA, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jacobs institute

Disqualifiers: Intracranial hemorrhage, ASPECTS<6, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new stent, the CGuard Prime™ Carotid Stent, to determine its safety and effectiveness for individuals experiencing a stroke due to narrowed neck arteries. The focus is on treating extracranial stenosis, where these arteries are at least 50% blocked, reducing blood flow to the brain. Ideal participants have experienced a stroke with symptoms such as difficulty speaking or moving and have been diagnosed with a large blood clot in the brain's main arteries. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for stroke patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have any contraindication (reason not to use) to dual antiplatelet therapy (using two medications to prevent blood clots).

What prior data suggests that the CGuard Prime™ Carotid Stent is safe for treating extracranial stenosis?

Research has shown that the CGuard Prime Carotid Stent has been tested for safety and effectiveness in treating carotid artery stenosis, a narrowing of the neck arteries. In a study involving 316 patients from the U.S. and Europe, the CGuard Prime demonstrated promising safety results. This study contributed to the FDA's approval of the stent, indicating it met certain safety standards for another condition.

The stent is designed to open narrowed arteries and improve blood flow, potentially reducing the risk of stroke. Although the study did not specify side effects, FDA approval suggests the device is generally safe when used correctly. However, understanding any potential risks or side effects is crucial, and your medical team can explain these before you decide to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The CGuard Prime™ Carotid Stent is unique because it features a mesh-covered design that offers enhanced protection against stroke. Unlike traditional carotid artery stents, which can sometimes allow small debris to pass through and cause blockages in the brain, the CGuard Prime™ has a micromesh that aims to trap this debris, potentially reducing the risk of stroke. Researchers are excited about this treatment because it represents a significant step forward in increasing the safety and effectiveness of carotid artery stenting procedures.

What evidence suggests that the CGuard Prime™ Carotid Stent is effective for treating extracranial stenosis in acute ischemic stroke?

Research shows that the CGuard Prime™ Carotid Stent, which participants in this trial will receive, holds promise for treating conditions related to stroke. In earlier studies, patients who received this stent had a low risk of serious problems like stroke or heart attack after the procedure. One study found a 4.2% chance of stroke on the same side as the treated artery and a 7.5% chance of the artery narrowing again after one year. Additionally, the CGuard Prime had the lowest rates of major problems at 30 days (0.95%) and one year (1.93%) compared to other studies. This evidence suggests that the stent effectively lowers risks linked to carotid artery stenosis, a narrowing of the arteries that can lead to strokes. ^{3 4 6 7 8}

Who Is on the Research Team?

CARLOS LOUIS PENA, PhD

Principal Investigator

Jacobs institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had a stroke due to at least 50% blockage in their carotid artery. They must have significant symptoms (NIHSS score of 6 or more) and evidence of a major blockage in the brain's blood vessels on a CT scan.

Inclusion Criteria

I am over 18, have a blocked artery in my neck, a stroke severity score of 6 or more, and a major artery blockage in my brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Placement of the CGuard Prime™ Carotid Stent in patients with extracranial stenosis during acute ischemic stroke

Immediate

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• CGuard Prime™ Carotid Stent

Trial Overview The study is testing the CGuard Prime™ Carotid Stent System's safety and early effectiveness when used to treat narrowed arteries outside the brain right after an acute ischemic stroke.

How Is the Trial Designed?

Group I: C Guard Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Jacobs institute

Lead Sponsor

Trials

3

Recruited

30+

Citations

1. inspiremd.com inspiremd.com/evidence/

Layers of Evidence Conclusion: Treatment with the CGuard™ carotid stent system with embolic protection had a low incidence of stroke, death, or MI post-procedure ...

2. inspiremd.com inspiremd.com/cguard-prime/

CGuard® Prime Musialek P et al. PARADIGM-Extend Prospective Academic Trial: Accumulating long-term evidence for MicroNet™-covered stent safety and stroke prevention efficacy.

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

One-Year Outcomes of CGuard Double Mesh Stent in Carotid ... The CLEAR-ROAD study showed a 4.2% ipsilateral stroke rate and 7.5% restenosis rate at 1 year [24]. The ROADSAVER is a prospective, multi-center ...

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

CGuard Prime carotid stent gains US and European ... CGuard Prime demonstrated the lowest 30-day (0.95%) and one-year (1.93%) primary endpoint major adverse event rates of any pivotal study of ...

5. 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 ...

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

summary of safety and effectiveness data (ssed) III. CONTRAINDICATIONS. The CGuard Prime Carotid Stent System is contraindicated for use in: • Patients in whom anti-coagulant and/or anti-platelet therapy ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/P240029C.pdf

TABLE OF CONTENTS The safety and efficacy of the CGuard Prime stent has not been demonstrated with embolic protection systems other than the Emboshield NAV6 and the Mo.Ma Ultra ...

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 ...