Vascular Surgery - Performance III
The Neuroguard IEP Direct System is a 3-in-1 carotid stent delivery system consisting of an angioplasty balloon, an integrated embolic protection device and a nitinol self-expanding stent loaded over the balloon and constrained by an outer sheath.
Criteria:
General Inclusion Criteria (with additional anatomical and angiographic inclusion criteria):
- 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
General Exclusion Criteria (with additional angiographic exclusion criteria):
- Life expectancy of less than one year in the opinion of the investigator at time of enrollment.
- Currently requiring an organ transplantation.
- An evolving acute stroke.
- Anticipated or existing potential sources of emboli including left ventricular aneurysm, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis, known previously symptomatic PFO, left atrial thrombus, any intracardiac mass.
- DVT or PE treated within the past 12 months requiring anticoagulation therapy, or any DVT or PE within 90 days of the index procedure.
- Recently (< 60 days) implanted heart valve.
- Subject has experienced any episode of paroxysmal atrial fibrillation or atrial flutter within the past 6 months or has a history of paroxysmal atrial fibrillation or atrial flutter requiring chronic anticoagulation.
- History of chronic atrial flutter or chronic atrial fibrillation.
- Anticoagulation with Phenprocoumon (Marcumar®), warfarin, direct thrombin inhibitors, or anti-Xa agents within 14 days prior to the index procedure.
- Subject with a known hypercoagulable state.
- Acute febrile illness (temperature ≥ 100.4 degrees F or 38 degrees C) or active infection.
- Subject with a SARS-CoV-2/COVID-19 infection within 21 days prior to the index procedure.
- Acute myocardial infarction (MI) < 30 days prior to index procedure.
- Any major surgical procedure (i.e., intraabdominal or intrathoracic surgery or any surgery / interventional procedure involving cardiac or vascular system) 30 days prior to or 30 days following the index procedure.
- History of disabling stroke with substantial residual disability (modified Rankin score ≥3).
- Subject has had a TIA or amaurosis fugax within 48 hours prior to the index procedure.
- Known severe carotid artery stenosis contralateral to the target lesion requiring treatment within 30 days of the index procedure.
- Any other neurological deficit not due to stroke that may confound neurological assessments.
- Subject has contralateral lateral recurrent, laryngeal or vagus nerve injury.
- Subject has severe dementia.
- Subject has an intracranial tumor.
- Known hypersensitivity to nitinol or its components (e.g., nickel, titanium).
- History of intracranial hemorrhage within the 12 months prior to the index procedure.
- History of GI bleed within 30 days prior to the index procedure that would interfere with antiplatelet therapy.
- Any condition that precludes proper angiographic assessment or makes direct carotid artery access unsafe (e.g., severe hepatic impairment, malignant hypertension, morbid obesity).
- Subject has less than 5 cm between the direct carotid access site and the proximal edge of the target lesion.
- Known hypersensitivity to contrast media that cannot be adequately premedicated.
- Hemoglobin (Hgb) < 8 gm/dL, platelet count < 100,000, INR > 1.5 (irreversible), or a history of heparin-induced thrombocytopenia.
- Chronic renal insufficiency (serum creatinine > 2.5 mg/dL or estimated GFR < 30 cc/min) or end-stage renal disease on hemodialysis on the day of the index procedure.
- History or current indication of bleeding diathesis or coagulopathy including
thrombocytopenia or an inability to receive heparin in amounts sufficient to achieve and/or maintain an activated clotting time (ACT) of ≥250 seconds, or uncorrectable severe anemia.
- Contraindication, intolerance or allergy to standard of care study medications, including antiplatelet therapy or aspirin.
- Previously enrolled in this study or currently enrolled in another interventional device or drug study that has not yet reached the primary endpoint.
- Potential for subject non-compliance with protocol-required follow up or antiplatelet medication in the opinion of the investigator.
- Subject is otherwise unsuitable for intervention or surgery in the opinion of the investigator.
Location: Hartford Hospital
Sponsor: Contego Medical
Contact: Kristy Wrana Kristy.Wrana@hhchealth.org 959-261-0327