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

NCT04900844 | Active Not Recruiting DMC FDA Device

• 1 other identifier: PRO-9017
• Study Type: interventional
• Target: 317
• Locations: 2 countries
• Sites: 18

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.

Conditions

Carotid Artery Stenosis

Keywords

Carotid Stenosis; Stenting; Prospective study; Embolic Protection Device (EPD); Carotid Artery Diseases; Cerebrovascular Disorders; Constriction, Pathologic

Outcome Measures

Primary Outcomes (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.

  From index procedure to 1 year follow up

Secondary Outcomes (9)

• 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 major 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 In-stent Restenosis (ISR) > 70% in ultrasound evaluation

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

Study Arms (1)

CGuard group

EXPERIMENTAL

Single experimental arm compared vs. objective performace goal

Device: CGuard Carotid Stent implantation

Interventions

CGuard Carotid Stent implantation DEVICE

Implantation of CGuard carotid stent in the eligible patients

Also known as: Carotid stenting

CGuard group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• InspireMD: lead

Study Sites (18)

University of Florida

Jacksonville, Florida, 32209, United States

Location

Oschner Health

New Orleans, Louisiana, 70121, United States

Location

Ascension, St. John Hospital

Detroit, Michigan, 48236, United States

Location

Mercy Hospital

St Louis, Missouri, 63141, United States

Location

University of Buffalo

Buffalo, New York, 14203, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Novant Health

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44103, United States

Location

UPMC-Pinnacle

Harrisburg, Pennsylvania, 17101, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Prisma Health-Upstate

Greenville, South Carolina, 29605, United States

Location

Avera Heart Hospital

Sioux Falls, South Dakota, 57108, United States

Location

Ballad CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

Ascension Seton, Seton Heart Institute

Austin, Texas, 78705, United States

Location

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

Katowice, Poland

Location

John Paul II Hospital

Krakow, Poland

Location

MeSH Terms

Conditions

Carotid Stenosis; Carotid Artery Diseases; Cerebrovascular Disorders; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris Metzger, MD

  Ballad Health

  PRINCIPAL INVESTIGATOR

• Piotr Musialek, MD DPhil

  John Paul II Hospital, Krakow, Poland

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 25, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: October 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

PL (2); US (16)