Pregnant patients or patients under the age of 18.Life threatening allergy to contrast media that could not be treated.Other abnormal angiographic findings that indicated the patient was at risk of a stroke due to a problem other than that of the target lesion, such as: ipsilateral arterial stenosis greater in severity than the target lesion, cerebral aneurysm, or arteriovenous malformation of the cerebral vasculature.Atherosclerotic disease involving adjoining vessels precluding safe placement of the guiding catheter or sheath.Hemoglobin (Hgb) 1.5 (irreversible), or heparin-associated thrombocytopenia.History or current indication of bleeding diathesis or coagulopathy including thrombocytopenia or an inability to receive heparin in amounts sufficient to maintain an activated clot time at > 250 seconds.Contraindication to aspirin, or to clopidogrel AND ticlopidine, or stent material.morbid obesity, sustained systolic blood pressure > 180 mmHg). Any condition that precluded proper angiographic assessment or made percutaneous arterial access unsafe, (e.g.History of intracranial hemorrhage within the past 3 months.History of ipsilateral stroke with fluctuating neurologic symptoms within 1 year.Evidence of a stroke within the previous 30 days.Presence of carotid artery dissection prior to initiation of the procedure.Vessel anatomy precluding the use of the stent system or appropriate positioning of the embolic protection system.Carotid string sign (a tiny, long segment of contrast in the true lumen of the artery).Previously placed stent in target artery.Low to moderate risk for adverse events from carotid endarterectomy.The safety and effectiveness of the Xact Carotid Stent System has NOT yet been established in patients with the characteristics noted below. When multiple stents are required, stent materials should be of similar composition.
Special consideration should be given to those patients with recently active gastritis or peptic ulcer disease. The appropriate antiplatelet and anticoagulation therapy should be administered pre- and post-procedure as suggested in these instructions. In patients requiring the use of antacids and / or H2-antagonists before or immediately after stent placement, oral absorption of antiplatelet agents (e.g. Stenting across a major bifurcation may hinder or prevent future diagnostic or therapeutic procedures. The long-term performance (> 1 year) of the Xact Carotid Stent System has not been established.Īs with any type of vascular implant, infection secondary to contamination of the stent may lead to thrombosis, pseudoaneurysm, or rupture. The safety and efficacy of the Xact Carotid Stent System has not been demonstrated with embolic protection systems other than the Emboshield Embolic Protection System. Refer to instructions supplied with all interventional devices to be used with the Xact Carotid Stent System for their intended uses, contraindications, and potential complications. Only physicians who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid interventional procedures should use this device.
Patients must have a reference vessel diameter ranging between 4.8 mm and 9.1 mm at the target lesion.Ĭontraindications associated with angioplasty must be considered when using the Xact Carotid Stent System. Patients with carotid artery stenosis (≥ 50% for symptomatic patients by ultrasound or angiography or ≥ 80% for asymptomatic patients by ultrasound or angiography), located between the origin of the common carotid artery and the intra-cranial segment of the internal carotid artery AND
The Xact Carotid Stent System (Xact), used in conjunction with the Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease and meet the criteria outlined below:
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