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- W2615192885 abstract "Mesh-covered carotid stents have been recently developed to reduce carotid artery stenting (CAS) intraprocedural cerebral embolization and prevent postprocedural adverse neurologic events related to the atherosclerotic plaque protrusion that occurred with prior-generation carotid stents. The aim of the present study was to evaluate periprocedural and 30-day outcomes in a prospective series of patients treated with the CGuard embolic prevention stent system (EPS). From April 2015 to June 2016, a physician-initiated prospective multicenter study was performed in consecutive patients admitted to protected CAS and treated using CGuard EPS in 12 vascular centers. Outcome measures were technical success, perioperative (0-24 hours) and postoperative (24 hours-30 days) major and minor stroke, death, acute myocardial infarction (AMI), transient ischemic attack (TIA), and external carotid occlusion. In addition, in three centers with feasibility of routine diffusion-weighted magnetic resonance cerebral imaging (DW-MRI), consecutive study patient DW-MRI was performed ≤72 hours before the intervention and after ≤72 hours. Target sample recruitment of 200 patients was reached per protocol. Distal embolic protection device was used in 182 patients, and a MoMa system was used in 18 patients (9%). An independent committee reviewed the events. Technical success was 100%; one patient required two stents to cover the entire lesion length. No death, AMI, or major stroke occurred perioperatively, but there were four periprocedural minor strokes (2%). In addition, there were 2 TIAs, 2 transient mental confusions, and 2 hemodynamic instabilities. At the 30-day follow-up, one stent was explanted due to partial thrombosis and clinical minor stroke (0.5%) in a patient who did not adhere to any antiplatelet drug postdischarge, and one other stent (that was nonoptimized at the index procedure due to hemodynamic instability) required postdilatation. In the remaining patients (198 of 200 [99%]), 1-month follow-up duplex ultrasound imaging revealed optimal technical result, and the clinical follow-up was uneventful. No external carotid artery occlusion occurred. In DW-MRI centers, 61 of 64 consecutive patients were evaluated per protocol (MRI contraindications prohibited imaging in 3). New postoperative DW-MRI lesions were detected in 12 patients (19.6%); six had contralateral-only and six had bilateral lesions. Real-world use of the CGuard EPS was associated with no major neurologic complications by 30 days. The system showed effective postprocedural protection against adverse neurologic events during stent healing.TableIRON-GUARD Study Group CollaboratorsFederico AccroccaCivitavecchia, Rome, ItalyDomenico AlbertiViterbo, ItalyGianmarco de DonatoSiena, ItalyMichelangelo FerriTurin, ItalyAndrea GaggianoAsti, ItalyGiuseppe GalzeranoSiena, ItalyArnaldo IppolitiRome, ItalyNicola MangialardiRome, ItalyGiovanni PratesiRome, ItalySonia RoncheyRome, ItalyMaria Antonella RuffinoTurin, ItalyAndrea SianiCivitavecchia, Rome, ItalyAngelo SpinazzolaCrema, ItalyMassimo SponzaUdine, Italy Open table in a new tab" @default.
- W2615192885 created "2017-05-26" @default.
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- W2615192885 date "2017-06-01" @default.
- W2615192885 modified "2023-10-18" @default.
- W2615192885 title "IF14. Thirty-Day Results From Prospective Multicenter Evaluation of Carotid Artery Stenting Using the CGuard Micronet-Covered Embolic Prevention Stent System in Real-World Population: the IRON-GUARD Study" @default.
- W2615192885 doi "https://doi.org/10.1016/j.jvs.2017.03.063" @default.
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