Carotid Artery StenosisNCT07277296
CGUARDIANS III IDE Pivotal Trial
A study testing SwitchGuardTM NPS in people with Carotid Artery Stenosis, run by InspireMD.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- SwitchGuardTM NPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Single-arm, Pivotal Study to Evaluate the Safety and Efficacy of the SwitchGuard™ Neuroprotection System (NPS) for Providing Cerebral Embolic Protection During Carotid Artery Stenting Via the Transcarotid Artery Revascularization (TCAR) Approach When Used in Conjunction With the CGuard™ Prime 80 Carotid Stent System
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.
Read the detailed description
This study is a prospective, multi-center, single arm pivotal study. The study shall not be blinded prior to, during or following the procedure. Patients undergoing transcarotid artery revascularization will be screened against the study inclusion/exclusion criteria. If the patient meets study eligibility requirements, they shall be invited to participate, provided informed consent and shall subsequently be assigned a study ID number.
Enrollment will be 103 pivotal patients. A maximum of 20% of patients will be enrolled at any single site. The total enrollment accounts for an estimate that up to 2 patients will exit the study prior to the 30-day primary endpoint assessment.
An additional roll-in cohort of up to 2 patients per primary physician operator at each study site may also be accrued (maximum of 50 roll-in patients total, assuming one primary physician operator per site).
This study does not duplicate any current knowledge existing today on use of the SwitchGuard NPS when used in conjunction with the CGuard Prime™ 80cm in the United States.
- Conditions
- Carotid Artery Stenosis
- Being tested
- SwitchGuardTM NPS
- Keywords
- Transcarotid Artery Revascularization, Carotid Endarterectomy
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SwitchGuardTM NPSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | SwitchGuardTM NPS Receives: Device: SwitchGuardTM NPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (17)
Rate of all death within 30 days of the procedure
Measured: 30 days
Rate of cardiac death within 30 days of the index procedure
Measured: 30 days
Rate of neurological death within 30 days of the index procedure
Measured: 30 days
Rate of all strokes within 30 days of the procedure
Measured: 30 days
Rate of major stroke within 30 days of the procedure
Measured: 30 days
Rate of minor stroke within 30 days of the procedure
Measured: 30 days
Rate of ipsilateral stroke within 30 days of the procedure
Measured: 30 days
Rate of MI within 30 days of the procedure
Measured: 30 days
Composite of death or stroke rate within 30 days of the procedure
Measured: 30 days
Rate of cranial nerve injury within 30 days of the procedure
Measured: 30 days
Access site complications (arterial/venous)
Measured: At procedure
All device-related serious adverse events within 30 days of the procedure
Measured: 30 days
Acute success for the SwitchGuard NPS
Successful insertion of the SwitchGuard NPS into the vasculature, followed by flow reversal, and the removal of the SwitchGuard NPS from the vasculature.
Measured: At procedure
Acute success for CGuard Prime 80cm Delivery System and Stent
Successful insertion of the delivery system, successful deployment of the stent, and successful retraction of the delivery system when used in conjunction with the SwitchGuard NPS.
Measured: At procedure
Technical Success for the CGuard Prime 80cm Delivery System and Stent
Technical Success Rate is defined as the number of patients with at least one CGuard Prime™ 80 device successfully delivered and deployed with final residual diameter stenosis < 30% following final post-balloon dilatation (if performed) divided by the total number of patients where CGuard Prime™ 80 device deployment was attempted when used in conjunction with the SwitchGuard NPS during a TCAR procedure.
Measured: At procedure
Procedural success
Acute device success for CGuard Prime 80cm Delivery System and Stent, AND acute device success for SwitchGuard NPS, AND freedom from the composite of death, all stroke or MI at 30-day post-procedure.
Measured: 30 days
Treatment Success for the CGuard Prime 80cm Delivery System and Stent
Treatment Success Rate is defined as the number of patients who meet CGuard Prime™ 80 Technical Success Rate without experiencing death, stroke or MI through 30-day post-procedure, divided by the total number of patients where CGuard Prime™ 80 device deployment was attempted when used in conjunction with the SwitchGuard NPS during a TCAR procedure.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InspireMD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick J Geraghty, MD, Principal investigator, Washington University School of MedicinePatrick Edward Muck, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277296
- Sponsor's protocol ID
- CGUARDIANS III
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Pivotal Study to Evaluate the Safety and Efficacy of the SwitchGuard™ Neuroprotection System (NPS) for Providing Cerebral Embolic Protection During Carotid Artery Stenting Via the Transcarotid Artery Revascularization (TCAR) Approach When Used in Conjunction With the CGuard™ Prime 80 Carotid Stent System
- ClinicalTrials.gov ID
- NCT07277296
- Acronym / sponsor ID
- CGUARDIANS III
- Conditions
- Carotid Artery Stenosis
- Keywords
- Transcarotid Artery Revascularization, Carotid Endarterectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- InspireMDIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, multi-center, single arm pivotal study. The study shall not be blinded prior to, during or following the procedure. Patients undergoing transcarotid artery revascularization will be screened against the study inclusion/exclusion criteria. If the patient meets study eligibility requirements, they shall be invited to participate, provided informed consent and shall subsequently be assigned a study ID number.
Enrollment will be 103 pivotal patients. A maximum of 20% of patients will be enrolled at any single site. The total enrollment accounts for an estimate that up to 2 patients will exit the study prior to the 30-day primary endpoint assessment.
An additional roll-in cohort of up to 2 patients per primary physician operator at each study site may also be accrued (maximum of 50 roll-in patients total, assuming one primary physician operator per site).
This study does not duplicate any current knowledge existing today on use of the SwitchGuard NPS when used in conjunction with the CGuard Prime™ 80cm in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: SwitchGuardTM NPSSwitchGuardTM NPS |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SwitchGuardTM NPSThe 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. | Device | Single Arm |
Primary outcome
Composite primary endpoint
Time frame: 30 days
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.
17 secondary outcomes
Rate of all death within 30 days of the procedure
Time frame: 30 days
Rate of cardiac death within 30 days of the index procedure
Time frame: 30 days
Rate of neurological death within 30 days of the index procedure
Time frame: 30 days
Rate of all strokes within 30 days of the procedure
Time frame: 30 days
Rate of major stroke within 30 days of the procedure
Time frame: 30 days
Rate of minor stroke within 30 days of the procedure
Time frame: 30 days
Rate of ipsilateral stroke within 30 days of the procedure
Time frame: 30 days
Rate of MI within 30 days of the procedure
Time frame: 30 days
Composite of death or stroke rate within 30 days of the procedure
Time frame: 30 days
Rate of cranial nerve injury within 30 days of the procedure
Time frame: 30 days
Access site complications (arterial/venous)
Time frame: At procedure
All device-related serious adverse events within 30 days of the procedure
Time frame: 30 days
Acute success for the SwitchGuard NPS
Time frame: At procedure
Acute success for CGuard Prime 80cm Delivery System and Stent
Time frame: At procedure
Technical Success for the CGuard Prime 80cm Delivery System and Stent
Time frame: At procedure
Procedural success
Time frame: 30 days
Treatment Success for the CGuard Prime 80cm Delivery System and Stent
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick J Geraghty, MD principal investigator
Washington University School of Medicine
Patrick Edward Muck, MD principal investigator
TriHealth Inc.
Questions about this trial
What is this clinical trial studying?
A study testing SwitchGuardTM NPS in people with Carotid Artery Stenosis, run by InspireMD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact InspireMD HCC ((800) 831-7819, HCC@hartclinicalconsultants.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite primary endpoint (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.