CGuard Prime Stent for Carotid Artery Disease

Recruiting at 7 trial locations

Overseen By InspireMD/NAMSA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: InspireMD

Must not be taking: Anticoagulants, Antiplatelets, Statins

Disqualifiers: Atrial fibrillation, Stroke, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

Trial Summary

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

How is the CGuard Prime Stent treatment different from other treatments for carotid artery disease?

The CGuard Prime Stent is unique because it features a mesh-covered design that helps prevent embolic events (blockages caused by debris) during carotid artery stenting, offering enhanced protection compared to traditional stents. This novel design aims to reduce the risk of stroke by capturing debris that might otherwise travel to the brain. ^{1 2 3 4 5}

What is the purpose of this trial?

The objective of this study is to evaluate acute device and technical success of the CGuard Prime™ Carotid Stent System (80cm) when used in conjunction with the Enroute NPS during Transcarotid Artery Revascularization procedures in the treatment of carotid artery stenosis in spatients at high risk for adverse events from carotid endarterectomy.

Research Team

Patrick J. Geraghty, MD

Principal Investigator

Washington University School of Medicine

Patrick E. Muck, MD

Principal Investigator

TriHealth Inc.

Eligibility Criteria

This trial is for adults aged 18-80 with carotid artery disease, either symptomatic stenosis ≥50% or asymptomatic stenosis ≥80%. Candidates must have a range of other health conditions like severe angina, heart failure, recent heart attack, or COPD. They should not have had certain neck treatments/surgeries and must be able to follow the study's procedures.

Inclusion Criteria

Age ≥ 70 (maximum 80 years) CCS angina class 3-4 or unstable angina Congestive Heart Failure (CHF) NYHA class III-IV Left ventricular ejection fraction (LVEF) ≤ 35% MI ≥ 72 hours and \< 6 weeks pre-procedure Multi-vessel CAD (≥ 2 vessels \>70% stenosis) and history of angina Chronic Obstructive Pulmonary Disease (COPD) with FEV1\<50 Permanent contralateral cranial nerve injury/paralysis Restenosis from previous carotid endarterectomy (CEA) Planned coronary artery bypass grafting (CABG) or valve replacement surgery between 31-60 days after CAS Abdominal aortic aneurysm surgical repair or Endovascular repair is planned between 31 to 60 days after CAS.

Occlusion of the contralateral CCA or ICA. Prior radiation treatment to the neck or a radical neck dissection. Severe bilateral ICA stenosis requiring treatment. Target lesion at or above the level of the jaw (C2) or below the clavicle. Severe tandem lesions Inability to extend the neck due to cervical disorders. Laryngeal palsy or laryngectomy. Prior head and neck surgery in the region of the carotid artery. Tracheostomy or tracheostoma. Spinal immobility of the neck. Hostile neck or surgically inaccessible lesion.

I have a narrowed carotid artery causing symptoms or it's severely narrowed without symptoms.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo transcarotid artery revascularization using the CGuard Prime Carotid Stent System and ENROUTE NPS

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1 year

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• CGuard Prime 80cm stent system

Trial Overview The CGuard Prime™ Carotid Stent System (80cm) is being tested in patients at high risk from traditional surgery. It's used with the ENROUTE Transcarotid Neuroprotection System during revascularization procedures to treat narrowed carotid arteries.

Participant Groups

Group I: CGuard Prime 80cm stent system with ENROUTE NPS Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

InspireMD

Lead Sponsor

Trials

8

Recruited

1,500+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

NAMSA

Collaborator

Trials

55

Recruited

21,500+

TriHealth Inc.

Collaborator

Trials

103

Recruited

54,100+

Findings from Research

The CGuard Carotid Embolic Protective Stent system was successfully used in 30 patients undergoing carotid artery stenting, achieving a 100% procedure success rate with no complications.

While 37% of patients developed new ischemic lesions immediately after the procedure, most of these lesions resolved by 30 days, indicating that the CGuard system may effectively reduce the risk of embolic events during the stent healing period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Multicenter Study of a Novel Mesh-Covered Carotid Stent: The CGuard CARENET Trial (Carotid Embolic Protection Using MicroNet). Schofer, J., Musiałek, P., Bijuklic, K., et al.[2017]

The CGuard micromesh self-expanding stent demonstrated 100% technical success and a 0% major adverse event rate at 30 days in a study of 103 patients undergoing carotid artery stenting, indicating its safety and efficacy.

Despite low usage of embolic protection devices (5.8%), the CGuard stent resulted in significant reductions in internal carotid artery stenosis and maintained 100% patency at 30 days, suggesting it effectively prevents complications associated with carotid artery stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thirty-Day Results of the Novel CGuard-Covered Stent in Patients Undergoing Carotid Artery Stenting. Tigkiropoulos, K., Papoutsis, I., Abatzis-Papadopoulos, M., et al.[2022]

The IRON-Guard Registry aims to evaluate the safety and efficacy of the C-Guard stent in carotid artery stenting (CAS) for patients with significant carotid artery stenosis, involving 200 subjects across multiple centers.

The primary focus of the study is to assess the 30-day rate of major adverse events (MAE), including death, stroke, or myocardial infarction, which will help determine the clinical outcomes of using the C-Guard stent compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician-initiated prospective Italian Registry of carotid stenting with the C-Guard mesh-stent: the IRON-Guard registry. Rationale and design. Setacci, C., Speziale, F., De Donato, G., et al.[2016]

The Angioguard emboli-capture guidewire system was technically feasible in 80% of cases during carotid artery stenting, effectively providing cerebral protection for most patients.

Despite the use of the filter device, new cerebral lesions were detected in 15% of patients after the procedure, indicating that microemboli can still occur, although no permanent neurological deficits were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical results of cerebral protection with a filter device during stent implantation of the carotid artery. Jaeger, H., Mathias, K., Drescher, R., et al.[2022]

In a study of 113 patients undergoing carotid artery stenting with the CGuard MicroNET stent, there was a very low incidence of serious complications, with only one stroke (0.8%) due to in-stent occlusion and no significant restenosis observed at 12 months.

The study indicates that the CGuard stent is a safe option for carotid artery stenting, showing minimal neurological adverse events, but further research is needed to assess its long-term safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

12-Month Outcomes of Carotid Artery Stenting With CGuard MicroNET-Covered Stent: A Single-Center Study in 113 Patients. Tigkiropoulos, K., Sidiropoulou, K., Abatzis-Papadopoulos, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Prospective, Multicenter Study of a Novel Mesh-Covered Carotid Stent: The CGuard CARENET Trial (Carotid Embolic Protection Using MicroNet). [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Thirty-Day Results of the Novel CGuard-Covered Stent in Patients Undergoing Carotid Artery Stenting. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Physician-initiated prospective Italian Registry of carotid stenting with the C-Guard mesh-stent: the IRON-Guard registry. Rationale and design. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical results of cerebral protection with a filter device during stent implantation of the carotid artery. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

12-Month Outcomes of Carotid Artery Stenting With CGuard MicroNET-Covered Stent: A Single-Center Study in 113 Patients. [2023]