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

Running, not enrolling · Not applicable

Conditions studied: Carotid Artery Stenosis

In brief

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.

Key facts

Study ID

NCT04900844

Run by

InspireMD

People needed

317

Starts

2021-07-01

Expected to finish

2025-10-01

Last updated by the study team

2025-04-04

Who can join

Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

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.
• 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.

Where it is running

• University of Florida — Jacksonville, Florida, United States
• Oschner Health — New Orleans, Louisiana, United States
• Ascension, St. John Hospital — Detroit, Michigan, United States
• Mercy Hospital — St Louis, Missouri, United States
• University of Buffalo — Buffalo, New York, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Stony Brook University Hospital — Stony Brook, New York, United States
• Novant Health — Winston-Salem, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• UPMC-Pinnacle — Harrisburg, Pennsylvania, United States
• Miriam Hospital — Providence, Rhode Island, United States
• Prisma Health-Upstate — Greenville, South Carolina, United States
• Avera Heart Hospital — Sioux Falls, South Dakota, United States
• Ballad CVA Heart Institute — Kingsport, Tennessee, United States
• Turkey Creek Medical Center — Knoxville, Tennessee, United States
• Ascension Seton, Seton Heart Institute — Austin, Texas, United States
• Leszek Leic Upper-Silesian Medical Centre of the Silesian Medical University — Katowice, Poland
• John Paul II Hospital — Krakow, Poland

Full record on ClinicalTrials.gov

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