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

InspireMD18 sites in 2 countries317 target enrollmentJuly 1, 2021

ConditionsCarotid Artery Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Carotid Artery Stenosis
Sponsor: InspireMD
Enrollment: 317
Locations: 18
Primary Endpoint: Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 1, 2021

End Date

October 1, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

InspireMD

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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:
•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.
•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)

Exclusion Criteria

•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.
•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.

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

Incidence of major ipsilateral stroke through discharge, 30 days, 6 months and 1-, 2-, 3-year follow-up.(From index procedure to 3 years follow up)
Composite of Ipsilateral stroke, stent thrombosis, cardiovascular death or other device related clinical events(From index procedure to 3 years follow up)
Incidence of DSMI through discharge, 30 days, 6 months, and yearly follow ups till 3 years(From index procedure to 3 years follow up)
Incidence of particular components of DSMI through discharge, 30 days, 6 months, and yearly follow ups till 3 years(From index procedure to 3 years follow up)
Incidence of ipsilateral stroke through discharge, 30 days, 6 months and 1-, 2-, 3-year follow-up.(From index procedure to 3 years follow up)
Incidence of target lesion revascularization(At 1-, 2-, 3-year post-index procedure follow-up)
Incidence of In-stent Restenosis (ISR) > 70% in ultrasound evaluation(At 1-, 2-, 3-year post-index procedure follow-up)
Incidence of In-stent Restenosis (ISR) > 50% in ultrasound evaluation(At 1-, 2-, 3-year post-index procedure follow-up)
Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure for subjects that adhere to antiplatelet pharmacology.(From index procedure to 1 year follow up)