CGUARDIANS III IDE Pivotal Trial

NCT07277296 | Not Yet Recruiting FDA Device

• 1 other identifier: CGUARDIANS III
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, multi-center, single-arm, pivotal study. The objective of this study is to evaluate the safety and efficacy of the SwitchGuard NPS in providing cerebral embolic protection during Transcarotid Artery Revascularization procedures using the CGuard Prime Carotid Stent System 80 in the treatment of carotid artery stenosis in patients at high risk for complications from CEA.

Conditions

Carotid Artery Stenosis

Keywords

Transcarotid Artery Revascularization; Carotid Endarterectomy

Outcome Measures

Primary Outcomes (1)

• Composite primary endpoint

  Incidence of the composite primary endpoint comprised of Death (all-cause mortality), all Stroke, or Myocardial Infarction (DSMI) through 30-days post-index procedure, based on Clinical Events Committee (CEC) adjudication.

  30 days

Secondary Outcomes (17)

• Rate of all death within 30 days of the procedure

  30 days

• Rate of cardiac death within 30 days of the index procedure

  30 days

• Rate of neurological death within 30 days of the index procedure

  30 days

• Rate of all strokes within 30 days of the procedure

  30 days

• Rate of major stroke within 30 days of the procedure

  30 days

Study Arms (1)

Single Arm

EXPERIMENTAL

SwitchGuardTM NPS

Device: SwitchGuardTM NPS

Interventions

SwitchGuardTM NPS DEVICE

The CGuard Prime™ 80 will be used in conjunction with the SwitchGuard™ NPS for the carotid artery stenting implantation procedure that will be performed by physician investigators experienced with transcarotid artery revascularization.

Single Arm

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
• Patient is diagnosed with carotid artery disease treatable with a Carotid Artery Stent via a Transcarotid Artery Revascularization approach and is either symptomatic or asymptomatic, defined as:
• Symptomatic carotid stenosis ≥ 50%. Symptomatic is defined as amaurosis fugax, transient ischemia attack (TIA) or stroke within the last 6 months ipsilateral to the side of the stenosis OR asymptomatic carotid stenosis ≥ 80%
• High Risk condition for CEA: at least one, as shown below:
• Comorbid conditions:
• Age ≥ 70 (maximum 82 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
• Anatomic conditions:
• 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

You may not qualify if:

• Patient had or will have an interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure
• Patient had or will have open heart surgery or valvular intervention (percutaneous or surgical), or any major operation, within 30 days before or after the index carotid procedure
• Vascular anatomy that would preclude safe sheath insertion or deliverability of stent
• Previously placed stent in the ipsilateral ICA or CCA
• Total occlusion or presence of a "string sign" of the ipsilateral ICA or CCA
• Presence of a filling defect of the target lesion
• Tandem lesions, which cannot be covered by a single CGuard Prime stent
• Stenosis of the innominate artery or proximal CCA requiring revascularization
• Open neck stoma
• History of bleeding diatheses or coagulopathy
• Hypercoagulable state
• Alternative source of cerebral embolus, including but not limited to:
• Chronic atrial fibrillation Episode(s) of paroxysmal atrial fibrillation within the past 6 months or history of paroxysmal atrial fibrillation requiring chronic anticoagulation Knowledge of cardiac sources of embolus (e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma) Recently (\<60 days) implanted heart valve (either surgically or endovascularly) as a known source of emboli as confirmed on echocardiogram, Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by angiography or CTA/MRA 6 months prior to index procedure) greater in severity than the lesion to be treated; cerebral aneurysm \> 5mm; AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings Known sensitivity or allergy to nickel or titanium.

Sponsors & Collaborators

• InspireMD: lead

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Patrick J Geraghty, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Patrick Edward Muck, MD

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

InspireMD HCC

CONTACT

(800) 831-7819; HCC@hartclinicalconsultants.com

Hart Clinical Consultants (HCC)

CONTACT

(800) 831-7819; HCC@hartclinicalconsultants.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 11, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-12