A Multicenter, Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System (80cm) When Used in Conjunction With the FDA-cleared ENROUTE Transcarotid Neuroprotection System (NPS) in Patients at High Risk for Adverse Events From Carotid Endarterectomy Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization (TCAR) Approach.
A Multicenter, Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System (80cm) When Used in Conjunction With the FDA-cleared ENROUTE Transcarotid Neuroprotection System (NPS) in Patients at High Risk for Adverse Events From Carotid Endarterectomy Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization (TCAR) Approach.
The objective of this study is to evaluate acute device and technical success of the CGuard Prime™ Carotid Stent System (80cm) when used in conjunction with the Enroute NPS during Transcarotid Artery Revascularization procedures in the treatment of carotid artery stenosis in spatients at high risk for adverse events from carotid endarterectomy.
This study is a prospective, multi-center, single arm pivotal study. The study shall not be blinded prior to, during or following the procedure. Patients undergoing transcarotid artery revascularization will be screened against the study inclusion/exclusion criteria. If the patient meets study eligibility requirements, they shall be invited to participate, provide informed consent and shall subsequently be assigned a study ID number.
Enrollment will be a minimum of 50 evaluable pivotal patients. A maximum of 20% of patients will be enrolled at any single site. The total enrollment accounts for an estimate that up to 2 patients will exit the study prior to the 30-day primary endpoint assessment.
An additional roll-in cohort of up to 2 patients per primary physician operator at each study site may also be accrued (maximum of 24 roll-in patients total, assuming one primary physician operator per site).
This study does not duplicate any current knowledge existing today on use of the CGuard Prime™ 80 used in conjunction with the ENROUTE NPS in the United States.
INCLUSION CRITERIA: Candidates for participation in the study must meet all of the following general inclusion criteria.
Comorbid conditions:
Anatomic conditions:
EXCLUSION CRITERIA: Patients are not eligible for the study if they have any of the following exclusion criteria.
Patient had or will have an interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure.
Patient had or will have open heart surgery or valvular intervention (percutaneous or surgical), or any major operation, within 30 days before or after the index carotid procedure.
Vascular anatomy that would preclude safe sheath insertion or deliverability of stent
Patient had a previously placed stent in the ipsilateral ICA or CCA.
Total occlusion or presence of a "string sign" of the ipsilateral ICA or CCA.
Presence of a filling defect of the target lesion.
Tandem lesions, which cannot be covered by a single CGuard Prime™ stent.
Patient has a stenosis of the innominate artery or proximal CCA requiring revascularization
Patient has an open neck stoma.
Patient has a history of bleeding diatheses or coagulopathy.
Patient has hypercoagulable state.
Patient has an alternative source of cerebral embolus, including but not limited to:
Patient has a known sensitivity or allergy to nickel or titanium.
Patient has a sensitivity to contrast media that cannot be adequately pre-treated.
Patient has a sensitivity to both forms of protocol-acceptable anticoagulation strategies (i.e., both heparin AND Bivalirudin)
Patient has a sensitivity to an antiplatelet agent AND all protocol acceptable alternative antiplatelet options
Patient has a known intolerance to statins.
Patient has a life expectancy of less than 3 years from the date of enrollment as determined by the Wallaert Life Expectancy Scale
Patient has malignancy, primary or recurrent, and does not have independent assessment of life expectancy performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.
Patient has an evolving stroke or intracranial hemorrhage, or a history of previous intracranial hemorrhage or brain surgery within the past 12 months.
Patient had a recent stroke (≤ 7 days) placing him/her at risk of a hemorrhagic conversion during the index procedure.
Patient has a history of a major stroke with a neurologic deficit (NIHSS of ≥ 15 or mRS ≥3).
Patient had a TIA or amaurosis fugax or stroke within 48 hours of the index procedure.
Female patient who is pregnant or lactating or is planning to become pregnant.
Dementia or other neurologic condition that is likely to confound the neurologic assessment.
Clinical condition that, in the opinion of the investigator, makes endovascular therapy impossible or hazardous.
Patient has been previously enrolled in this clinical trial.
Patient is likely to be non-compliant with protocol-required follow up or medication in the opinion of the investigator.
Patient is currently participating in another clinical trial that has not completed its primary endpoint assessment or that may confound this study results.
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