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Carotid Artery StenosisC-GuardiansNCT04900844

Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting

A study testing CGuard Carotid Stent implantation in people with Carotid Artery Stenosis, run by InspireMD at 18 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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 in symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS) to a performance goal developed from published CAS literature. Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Carotid Artery Stenosis
What is being tested?
CGuard Carotid Stent implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
317 participants
Where
18 sitesin 2 countries
Study dates
1 Jul 2021to 1 Oct 2025
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 19 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
  • Subject is willing and able to take dual antiplatelet therapy for a minimum of 30 days.
  • Life expectancy ≥ 24 months from the date of the index procedure.
  • Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.
  • Subject has a modified Rankin Score of ≤ 2at the time of informed consent.
  • Subject is diagnosed with carotid artery disease treatable with carotid artery stenting and is considered high risk for carotid endarterectomy (CEA) as evidenced by:
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  • 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%
  • Co-Morbidity High Risk Conditions for CEA, i.e., meets one or more of the following 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 repair or peripheral vascular surgery is planned between 31 to 60 days after CAS.
  • OR
  • High Anatomical Risk for CEA, i.e., meets one or more of the following criteria:
  • 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 hear 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.
  • 10. Angiographic General Inclusion Criteria, i.e., meets all the following criteria:
  • Target lesion location at the carotid bifurcation and/or proximal internal carotid artery (ICA)
  • Vessel distal to target lesion can accommodate a distal embolic protection device (EPD), and EPD is compatible with CGuard™ device (refer to CGuard™ System IFU for specific EPDs).
  • Target vessel reference diameter at stent landing zone is 4.8 mm to 9.0 mm.
  • Target lesion length ≤ 36 mm, that can be covered by a single CGuard™ stent.

Who cannot join

  • Planned interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure.
  • Severe vascular anatomy that would preclude safe sheath insertion, deliverability of stent or embolic protection device.
  • Type III or bovine aortic arch.
  • Total occlusion of the target vessel.
  • Presence of "String sign" of the target lesion.
  • In-tandem lesions with >= 50% or >= 80% diameter stenosis for symptomatic or asymptomatic patients, respectively, which cannot be covered by a single CGuard™ stent.
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  • History of bleeding diatheses or coagulopathy or inability to accept blood transfusions.
  • Bilateral carotid stenosis requiring treatment on both sides within 30 days prior to or following planned index procedure.
  • Subject is on renal replacement therapy or has Stage 4 or 5 Chronic Kidney Disease (CKD).
  • Known reason for potential stroke other than carotid artery stenosis, including history of atrial fibrillation or other sources of thromboemboli within the past 12 months.
  • History of thrombophilia.
  • Known sensitivity or allergy to nitinol, titanium, heparin, aspirin or other anticoagulant/ antiplatelet therapies.
  • Contrast media sensitivity or allergy that cannot be pre-treated.
  • Previous stent placement in the target vessel.
  • Evolving stroke or intracranial hemorrhage, or history of previous intracranial hemorrhage or brain surgery within the past 12 months.
  • Major neurologic deficit with NIHSS of ≥ 15.
  • Dementia or other neurologic condition confounding the neurologic assessment.
  • Clinical condition that, in the opinion of the investigator, makes endovascular therapy impossible or hazardous.
  • Subject previously enrolled in this clinical trial.
  • Possible / probable non-compliance of subject with protocol required follow up or medication.
  • Subject is currently participating in another clinical trial that has not completed its primary endpoint assessment or would confound this C-GUARDIANS Pivotal IDE Clinical Study.
  • SARS-CoV2 (COVID-19) active infection.

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

United States16 sites

  • Ascension Seton, Seton Heart Institute

    Austin, Texas, 78705

  • University of Buffalo

    Buffalo, New York, 14203

  • Cleveland Clinic

    Cleveland, Ohio, 44103

  • Ascension, St. John Hospital

    Detroit, Michigan, 48236

  • Prisma Health-Upstate

    Greenville, South Carolina, 29605

  • UPMC-Pinnacle

    Harrisburg, Pennsylvania, 17101

  • University of Florida

    Jacksonville, Florida, 32209

  • Ballad CVA Heart Institute

    Kingsport, Tennessee, 37660

  • Turkey Creek Medical Center

    Knoxville, Tennessee, 37934

  • Oschner Health

    New Orleans, Louisiana, 70121

  • Columbia University Irving Medical Center

    New York, New York, 10032

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • Avera Heart Hospital

    Sioux Falls, South Dakota, 57108

  • Mercy Hospital

    St Louis, Missouri, 63141

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • Novant Health

    Winston-Salem, North Carolina, 27103

Other trials in United States

Poland2 sites

  • Leszek Leic Upper-Silesian Medical Centre of the Silesian Medical University

    Katowice

  • John Paul II Hospital

    Krakow

Other trials in Poland

About this study

Official title: A Multicenter, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the CGuard™ Carotid Stent System When Used to Treat Symptomatic and Asymptomatic Carotid Artery Stenosis in Patients Undergoing Carotid Artery Stenting

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 in symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS) to a performance goal developed from published CAS literature.

Being tested
CGuard Carotid Stent implantation
Keywords
Carotid Stenosis, Stenting, Prospective study, Embolic Protection Device (EPD), Carotid Artery Diseases, Cerebrovascular Disorders, Constriction, Pathologic
Medical subject headings
Carotid Stenosis, Carotid Artery Diseases, Cerebrovascular Disorders, Constriction, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CGuard Carotid Stent implantationDevice

    Also called Carotid stenting

    Implantation of CGuard carotid stent in the eligible patients

Study groups in NCT04900844
Study groupRoleWhat they receive
CGuard groupExperimentalSingle experimental arm compared vs. objective performace goal
Receives: Device: CGuard Carotid Stent implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure

    The primary endpoint is the composite of the following:

    • Incidence of the following Major Adverse Events: Death (allcause mortality), all Stroke, and Myocardial Infarction (DSMI) through 30-days post-index procedure, based on Clinical Events Committee (CEC) adjudication OR
    • Ipsilateral stroke from 31-365 day follow-up, based on Clinical Events Committee (CEC) adjudication.

    Measured: From index procedure to 1 year follow up

Secondary outcomes (9)

  1. Incidence of DSMI through discharge, 30 days, 6 months, and yearly follow ups till 3 years

    Incidence of the following composite of Major Adverse Events: Death (all-cause mortality), all Stroke, and Myocardial Infarction (DSMI) through discharge, 30-days, 6-months, and 1-,2-,3-year follow-up, based on Clinical Events Committee (CEC) adjudication.

    Measured: From index procedure to 3 years follow up

  2. Incidence of particular components of DSMI through discharge, 30 days, 6 months, and yearly follow ups till 3 years

    Incidence of each individual component of the Major Adverse Events: Death (all-cause mortality), all Stroke, and Myocardial Infarction (DSMI) through discharge, 30-days, 6-months, and 1-,2-,3-year follow-up, based on Clinical Events Committee (CEC) adjudication.

    Measured: From index procedure to 3 years follow up

  3. Incidence of ipsilateral stroke through discharge, 30 days, 6 months and 1-, 2-, 3-year follow-up.

    Ipsilateral stroke through discharge, 30 days, 6 months and 1-, 2-, 3-year follow-up.

    Measured: From index procedure to 3 years follow up

  4. Incidence of major ipsilateral stroke through discharge, 30 days, 6 months and 1-, 2-, 3-year follow-up.

    Major ipsilateral stroke through discharge, 30 days, 6 months and 1-, 2-, 3-year follow-up.

    Measured: From index procedure to 3 years follow up

  5. Incidence of In-stent Restenosis (ISR) > 70% in ultrasound evaluation

    Incidence of In-stent Restenosis (ISR) > 70%. ISR > 70% is defined as PSV > 300 cm/s associated with stent, or vessel occlusion based on transcervical duplex ultrasound through

    1-, 2-, 3-year follow-up. Based on Imaging Core Laboratory assessment.

    Measured: At 1-, 2-, 3-year post-index procedure follow-up

  6. Incidence of In-stent Restenosis (ISR) > 50% in ultrasound evaluation

    Incidence of In-stent Restenosis (ISR) > 50%. ISR > 50% is defined as PSV > 220 cm/s associated with stent, or vessel occlusion based on transcervical duplex ultrasound through

    1-, 2-, 3-year follow-up. Based on Imaging Core Laboratory assessment.

    Measured: At 1-, 2-, 3-year post-index procedure follow-up

  7. Incidence of target lesion revascularization

    Incidence of Target Lesion Revascularization (TLR) through 1-,2,3-year follow-up. TLR is defined as clinically driven revascularization procedure of the original treatment site, including angioplasty, stenting, endarterectomy, or thrombolysis, performed to open or increase the luminal diameter within the stented lesion or within 5 mm proximal or distal to the index stent.

    Measured: At 1-, 2-, 3-year post-index procedure follow-up

  8. Composite of Ipsilateral stroke, stent thrombosis, cardiovascular death or other device related clinical events

    Ipsilateral stroke, stent thrombosis, cardiovascular death or other device related clinical events from discharge up to 1-,2- and 3-year follow-up.

    Measured: From index procedure to 3 years follow up

  9. Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure for subjects that adhere to antiplatelet pharmacology.

    Primary endpoint for subjects that adhere to antiplatelet pharmacology.

    Measured: From index procedure to 1 year follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2021
  2. Study start1 Jul 2021
  3. Primary completion1 Jul 2022
  4. Study completion1 Oct 2025 (estimated)

Resources

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
Model description
This is a single-arm trial, where the primary endpoint will be compared to a performance goal. The null hypothesis will be rejected (i.e. performance goal is met) if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is \< 11.6% and the p-value is less than 0.025.
Masking
None (open label)
Enrolment
317 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04900844
Sponsor's protocol ID
PRO-9017
Acronym
C-Guardians
Status last verified
Apr 2025
First submitted
20 May 2021
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing CGuard Carotid Stent implantation in people with Carotid Artery Stenosis, run by InspireMD at 18 sites in 2 countries.

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 39 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure (time frame: From index procedure to 1 year follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04900844.

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 4 Apr 2025.

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