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. 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. 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. 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. 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. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.
Layout table for location contacts Contact: Christina Brennan christinab inspiremd. More Information. National Library of Medicine U. National Institutes of Health U. Clinical results of carotid artery stenting compared with carotid endarterectomy. J Vasc Surg ;47 2 —9. Safety of carotid artery stenting for symptomatic carotid artery disease: a meta-analysis. Eur Heart J ;29 1 —9. Stent-pro-tected angioplasty versus carotid endarterectomy in patients with carotid artery stenosis: meta-analysis of randomized trial data.
Eur Radiol ;18 12 — Endarterectomy vs stenting for carotid artery stenosis: a systematic review and meta-analysis. J Vasc Surg ;48 2 — Percutaneous transluminal angioplasty and stenting for carotid artery stenosis. Carotid angioplasty with or without stent placement versus carotid endarterectomy for treatment of carotid stenosis: a meta-analysis.
Neurosurgery ;56 6 — Xact Carotid Stent System—P Summary of safety and effectiveness data. Catheter Cardiovasc Interv ;73 2 — CAS clinical trial and registry update. Endovasc Today Sept;—9. J Vasc Surg ;44 2 — Carotid stenting with distal protection in high surgical risk patients: the BEACH trial 30 day results. Catheter Cardiovasc Interv ;67 4 — Protected carotid stenting in high-risk patients with severe carotid artery stenosis. J Am Coll Cardiol ;47 12 —9.
Jokhi PP, Saw J. Carotid stenting registries and randomized trials. In: Saw J, editor. Carotid artery stenting: the basics. Totowa NJ : Humana Press; Multicenter evaluation of a self-expanding carotid stent system with distal protection in the treatment of carotid stenosis. Embolic protection with filtering or occlusion balloons during saphenous vein graft stenting retrieves identical volumes and sizes of particulate debris.
Circulation ; 14 — Proximal endovascular flow blockage for cerebral protection during carotid artery stenting: results from a prospective multicenter registry. J Endovasc Ther ;12 2 — The CAPTURE registry: analysis of strokes resulting from carotid artery stenting in the post approval setting: timing, location, severity, and type.
Ann Surg ; 4 —8. The CAPTURE registry: predictors of outcomes in carotid artery stenting with embolic protection for high surgical risk patients in the early post-approval setting. Catheter Cardiovasc Interv ;70 7 — Catheter Car-diovasc Interv ;69 3 —8. J Cardiovasc Surg Torino ;46 3 —7. Risk-adjusted day outcomes of carotid stenting and endarterectomy: results from the SVS Vascular Registry.
J Vasc Surg ;49 1 —9. Eur Heart J ;28 3 —5. J Am Coll Cardiol ;49 1 — The type of embolic protection does not influence the outcome in carotid artery stenting.
J Vasc Surg ; 46 2 —6. Early outcome of carotid angioplasty and stenting with and without cerebral protection devices: a systematic review of the literature. Stroke ;34 3 —9. Updated review of the global carotid artery stent registry.
Catheter Cardiovasc Interv ; 60 2 — Protection or nonprotection in carotid stent angioplasty: the influence of interventional techniques on outcome data from the SPACE Trial [published erratum appears in Stroke ;40 6 :e].
Stroke ;40 3 —6. Filter-protected versus unprotected carotid artery stenting: a randomised trial. Cerebrovasc Dis ;29 3 —9. White CJ. J Am Coll Cardiol ;55 16 — First clinical experiences with an endovas-cular clamping system for neuroprotection during carotid stenting. Eur J Vasc Endovasc Surg ;28 6 — Cerebral protection during carotid stenting using flow reversal. J Vasc Surg ;41 3 — Effect of two different neuropro-tection systems on microembolization during carotid artery stenting.
J Am Coll Cardiol ;44 10 —9. Proximal endovascular occlusion for carotid artery stenting: results from a prospective registry of 1, patients. J Am Coll Cardiol ;55 16 —7. Guidelines for carotid end-arterectomy: a statement for healthcare professionals from a Special Writing Group of the Stroke Council, American Heart Association. Circulation ;97 5 —9. Circulation ; 24 :e— Circulation ; 10 :e— Eur J Vasc Endovasc Surg ;41 2 —8.
Impact of diabetes, patient age, and gender on the day incidence of stroke and death in patients undergoing carotid artery stenting with embolus protection: a post-hoc subanalysis of a prospective multicenter registry. J Endovasc Ther ;14 3 —8. Systematic preoperative coronary angiography and stenting improves postoperative results of carotid endar-terectomy in patients with asymptomatic coronary artery disease: a randomised controlled trial.
Eur J Vasc Endovasc Surg ;39 2 — Catheter Cardio-vasc Interv ;77 4 — Support Center Support Center. As less-invasive revascularization techniques with stents evolved and became more successful, pivotal trials were performed to obtain FDA approval, and head-to-head comparisons with CEA were performed. At 3 years, there was no difference for major adverse cardiac events, death, or stroke.
In 1, asymptomatic patients, the primary composite endpoint of death, stroke, or MI within 30 days of the procedure or ipsilateral stroke within 1 year was not inferior for CAS 3. After 5 years of follow-up, the stroke-free survival was not different at The American College of Cardiology and American Heart Association AHA guideline on the management of patients with extracranial carotid and vertebral artery disease was broadly endorsed by 14 professional societies, including the Society of Vascular Surgery, the American College of Radiology, and the Society of Vascular Medicine.
Next, there is direct carotid access with high flow reversal with transcarotid artery revascularization TCAR using the Enroute device Silk Road Medical. This technology allows for a small surgical incision above the clavicle for direct carotid access and initiation of high flow reversal into a venous circuit with a filter to protect the brain from stroke while delivering and implanting the Enroute Transcarotid Stent.
Additionally, TCAR showed fewer diffusion-weighted imaging abnormalities after the procedure and comparable to carotid endarterectomy, which Gray said demonstrates mechanistic proof of improved embolic protection. The recent development of mesh-covered stents, which may overcome the risk for distal embolization related to plaque protrusion through stent struts, may actually mean the stent is part of the embolic protection strategy.
This is a big advance in the field. To date, testing with the CGuard has shown reductions in diffusion-weighted imaging abnormalities, according to Gray.
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