CGuard Prime Stent for Carotid Artery Disease
Recruiting in Palo Alto (17 mi)
Overseen byPatrick E. Muck, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: InspireMD
Must not be taking: Anticoagulants, Antiplatelets, Statins
Disqualifiers: Atrial fibrillation, Stroke, Pregnancy, others
No Placebo Group
Trial Summary
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.
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.
12345Eligibility 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
I am between 18 and 79 years old and can follow the study's requirements.
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.
+3 more
Trial 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)
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: CGuard Prime 80cm stent system with ENROUTE NPSExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington University School of MedicineSaint Louis, MI
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Who Is Running the Clinical Trial?
InspireMDLead Sponsor
Washington University School of MedicineCollaborator
NAMSACollaborator
TriHealth Inc.Collaborator
References
A Prospective, Multicenter Study of a Novel Mesh-Covered Carotid Stent: The CGuard CARENET Trial (Carotid Embolic Protection Using MicroNet). [2017]This study sought to evaluate the feasibility of the CGuard Carotid Embolic Protective Stent system-a novel thin strut nitinol stent combined with a polyethylene terephthalate mesh covering designed to prevent embolic events from the target lesion in the treatment of carotid artery lesions in consecutive patients suitable for carotid artery stenting.
Thirty-Day Results of the Novel CGuard-Covered Stent in Patients Undergoing Carotid Artery Stenting. [2022]The aim of this study was to provide early-term evaluation, safety, and efficacy of the novel CGuard (Inspire MD, Tel Aviv, Israel) micromesh self-expanding stent with embolic protection system (EPS) during carotid artery stenting (CAS) procedure.
Physician-initiated prospective Italian Registry of carotid stenting with the C-Guard mesh-stent: the IRON-Guard registry. Rationale and design. [2016]According to the World Health Organization, every year, 5 million peoples die for stroke and another 5 million are permanently disabled. Although there are many causes of acute stroke, a common treatable cause of acute stroke is atheromatous narrowing at the carotid bifurcation. Carotid endarterectomy is still the standard of car, even if carotid artery stenting (CAS) has become an effective, less invasive alterantive. Unfortunately, CAS procedure is not yet perfect; regardless the use of an embolic protection device (EPD), percutaneous treatment has been correlated with a risk of cerebral ischemic events related to distal embolization. The objective of the IRON-Guard Registry is to evaluate the clinical outcome of treatment by means of stenting with the C-Guard (InspireMD, Boston, MA, USA) in subjects requiring CAS due to significant extracranial carotid artery stenosis with a physician-initiated, Italian, prospective, multicenter, single-arm study. A total of 200 enrolled subjects divided over different centers are planned to be enrolled. CAS will performed by implanting of C-Guard stent. Procedure will be performed according to the physician's standard of care. Standard procedures will be followed based on the Instructions for Use, for the C-Guard device of Inspire. The primary endpoint of this study is the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any periprocedural (≤30 days postprocedure) death, stroke or myocardial infarction. Secondary endpoints are rate of late ipsilateral stroke (31 through 365 days), system technical success, device malfunctions, major adverse events (MAEs), serious device-related and procedure-related adverse events, target lesion revascularization, and in-stent restenosis rates.
Clinical results of cerebral protection with a filter device during stent implantation of the carotid artery. [2022]To assess the technical feasibility and the clinical results of cerebral protection with the Angioguard emboli-capture guidewire system during carotid artery stenting (CAS) for high-grade stenoses.
12-Month Outcomes of Carotid Artery Stenting With CGuard MicroNET-Covered Stent: A Single-Center Study in 113 Patients. [2023]Dual layer mesh stents constitute a novel treatment option for patients who undergo carotid artery stenting (CAS). The aim of this prospective study is to report 12 month outcomes of patients who underwent CAS with CGuard (Inspire MD, Tel Aviv, Israel) microNET self-expanding stent with embolic protection system in a tertiary center from October 2018 to March 2022. Primary endpoints included in-stent restenosis >70% verified by ultrasound (DUS), ipsilateral transient ischemic attack (TIA), and stroke at 12 months. Secondary endpoints included cardiovascular-related mortality (stroke, myocardial infarction, heart failure) and all-cause mortality during follow-up. One hundred thirteen patients were included in the study (male 72.5%), symptomatic 47.8%. Median follow-up was 25 months (2-48). By 12 months, there was one in-stent occlusion that manifested as stroke (1/113, 0.8%) but no other forms of in-stent restenosis. Two patients experienced contralateral TIA (1.7%). CVRM was 3.5% (4 MI) and all-cause mortality was 6% at follow-up. This prospective study shows that CAS with CGuard MicroNET-covered stent is safe with minimal neurological adverse events at 12 months follow-up. Larger, and longer-term studies are necessary to define CGuard long-term safety and protection against carotid-related stroke.