NCT04900844Active, not recruitingNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- InspireMD
- Enrollment
- 317
- Locations
- 34
- Primary Endpoint
- Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •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.
- •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.
- •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.
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.
- •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 ≥
- •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.
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)
Investigators
Study Sites (34)
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