Protection Against Emboli During caRotid Artery Stenting Using a Neuroguard IEP® Direct 3-in-1 Delivery System Comprised oF a pOst-dilation Balloon, integRated eMbolic Filter, and A Novel Carotid stEnt - the PERFORMANCE III Study
The PERFORMANCE III study is a prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP® Direct System for the treatment of carotid artery stenosis in subjects at elevated risk for carotid endarterectomy (CEA). Eligible patients greater than or equal to 20 years of age and less than or equal to 80 years of age, are those who have been diagnosed with either de-novo atherosclerotic or post CEA restenotic lesion(s) in the internal carotid arteries (ICA) or at the carotid bifurcation with greater than or equal to 50% stenosis if symptomatic or greater than or equal to 70% stenosis if asymptomatic.
• Male and non-pregnant, non-breastfeeding female subjects whose age is ≥ 20 or ≤ 80 years of age.
• Subject is willing and capable of complying with and understands all study protocol requirements, including the specified follow-up visits, and can be contacted by telephone.
• Subject has signed a written informed consent form that has been approved by the local governing Institutional Review Board (IRB) of the respective clinical site.
• Subject is diagnosed with carotid artery stenosis treatable with carotid artery stenting via direct carotid access and is considered a high operative risk for carotid endarterectomy (CEA).
• Subject is diagnosed with either:
∙ Symptomatic carotid stenosis ≥ 50% as determined by angiography, CTA, or duplex ultrasound. Symptomatic is defined as having stroke, transient ischemic attack (TIA) in the ipsilateral hemisphere supplied by the target vessel carotid lesion or ipsilateral transient monocular blindness (amaurosis fugax) within 180 days prior to the procedure; or
‣ Asymptomatic carotid stenosis ≥ 70% as determined by angiography, CTA, or duplex ultrasound.
• Subject has a lesion located in the internal carotid artery (ICA) and/or common carotid artery (CCA).
• Subject has a modified Rankin Scale of ≤ 2 at the time of procedure.
• Females of child-bearing potential have a negative pregnancy test within 24 hours prior to the index procedure.
• Subject is willing and able to take dual anti platelet therapy for a minimum of 30 days following the index procedure.
⁃ Subject meets at least one physiologic or one anatomic high-risk criteria.
• Anatomic High-Risk Conditions for CEA
• 1\. Target lesion at or above C2 (level of jaw). 2. Prior head and neck surgery in the region of the carotid artery. 3. Tracheostomy or tracheostoma. 4. Surgically inaccessible lesion or hostile neck which the investigator deems safe for direct carotid access including but not limited to:
• Prior neck irradiation
• Radial neck dissection
• Cervical spine immobility 5. Prior ipsilateral CEA. 6. Prior cranial nerve injury. 7. Severe tandem lesions. 8. Occlusion of the contralateral CCA or ICA. 9. Severe bilateral ICA stenosis.
• Physiological High-Risk Conditions for CEA
‣ Subject is ≥ 70 years of age (maximum 80 years) at the time of enrollment.
‣ Subject has NYHA Class III or IV congestive heart failure (CHF).
‣ Subject has chronic obstructive pulmonary disease (COPD) with FEV1 \< 50, on intermittent or chronic oxygen therapy, or a resting PO2 of ≤ 60 mmHg (room air).
• 4 Subject has left ventricular ejection fraction (LVEF) ≤ 35%. 5. Subject has angina class 3 or 4 or unstable angina. 6. Subject has a history of recent myocardial infarction (between 30 days and 6 weeks prior to index the procedure).
• 7\. Subject has coronary artery disease with two or more vessels with ≥ 70% stenosis.
• 8\. Subject has planned coronary artery bypass grafting (CABG) or peripheral vascular surgery between 31 and 60 days after index procedure.
• 9\. Subject has restenosis following a prior carotid endarterectomy (CEA).
• Angiographic Inclusion Criteria
‣ Subject has a lesion located in the internal carotid artery (ICA) and/or common carotid artery (CCA).
‣ Single de novo or restenotic (post carotid endarterectomy \[CEA\]) target lesion or severe tandem lesions that can be covered by a single Neuroguard stent.
‣ Target lesion is treatable with a single stent of up to 40 mm in length.
‣ Index vessel diameter (segment covered by the mid-portion of the stent) is between 4.0 mm and 6.0 mm at the site of the target lesion.
‣ Distal vessel diameter at the site of Neuroguard filter deployment is between 4.0 mm and 7.0 mm.
‣ Distal common carotid artery diameter (segment covered by proximal portion of the stent) is between 4.0 mm and 8.0 mm.
‣ Sufficient landing zone exists in the cervical internal carotid artery distal to the target lesion to allow for the safe and successful deployment of the integrated Neuroguard filter.
‣ At least 5 cm of atherosclerosis free space in the ipsilateral common carotid artery between the sheath insertion site and the proximal edge of the target lesion.
‣ Common carotid artery reference diameter is at least 6 mm.
∙ Target vessel must meet diameter requirements as set forth in the Neuroguard IEP Direct System Instructions for Use (IFU).