Department for Angiology, Brandenburg Medical School Theodor Fontane, Campus Clinic Brandenburg, Center for Internal Medicine I, Berlin, Germany.
Department of Angiology, Sankt-Gertrauden-Krankenhaus, Berlin, Germany.
Catheter Cardiovasc Interv. 2022 Nov;100(6):1090-1099. doi: 10.1002/ccd.30410. Epub 2022 Oct 13.
The PERFORMANCE I study was designed to evaluate the safety and feasibility of the Neuroguard IEP® System, a novel carotid stent system with an integrated embolic filter and post-dilatation balloon, to treat clinically significant carotid artery stenosis.
The risk of major adverse events during carotid artery stenting is comparable to carotid endarterectomy, however, the risk of minor stroke remains higher with stenting.
In total, 67 patients undergoing carotid artery stenting were enrolled at nine centers in Europe. Follow-up assessments included neurological exams, duplex ultrasound, 12-lead electrocardiogram, and cardiac enzyme analysis. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarctions versus a prespecified performance goal. Secondary endpoints included procedure success, device success, and target lesion revascularization.
The study population was predominantly male (74.6%) with a mean age of 69.3 ± 8.9 years and 67% of subjects met at least one criterion placing them at an elevated risk for adverse events following carotid endarterectomy. All patients were treated successfully with the study device. There were no deaths or strokes within 30 days of the index procedure. One subject (1.5%) experienced a non-ST elevation myocardial infarction at day 17. The primary endpoint was met with a 30-day major adverse events rate of 1.5% (1/67). Through 12-month follow-up, there were no strokes, neurological deaths, target lesion revascularizations, or instances of in-stent-restenosis.
Results from this study demonstrate the Neuroguard IEP system is safe and feasible with a stroke/death rate of 0% at 30 days. A large pivotal study is currently underway.
PERFORMANCE I 研究旨在评估 Neuroguard IEP® 系统的安全性和可行性，这是一种新型的颈动脉支架系统，具有集成的栓塞过滤器和后扩张球囊，用于治疗有临床意义的颈动脉狭窄。
颈动脉支架置入术的主要不良事件风险与颈动脉内膜切除术相当，但支架置入术的小中风风险仍然较高。
在欧洲的 9 个中心共招募了 67 例接受颈动脉支架置入术的患者。随访评估包括神经检查、双功超声、12 导联心电图和心脏酶分析。主要终点是 30 天内卒中、死亡和心肌梗死的复合发生率与预设的性能目标相比。次要终点包括手术成功率、器械成功率和靶病变血运重建。
研究人群主要为男性（74.6%），平均年龄为 69.3±8.9 岁，67%的患者至少符合一项标准，使他们在颈动脉内膜切除术后发生不良事件的风险升高。所有患者均成功接受研究器械治疗。指数手术后 30 天内无死亡或卒中。1 例（1.5%）患者在第 17 天发生非 ST 段抬高型心肌梗死。主要终点的 30 天主要不良事件发生率为 1.5%（1/67）。在 12 个月的随访中，无卒中、神经源性死亡、靶病变血运重建或支架内再狭窄发生。
这项研究的结果表明，Neuroguard IEP 系统是安全可行的，30 天的卒中/死亡率为 0%。目前正在进行一项大型关键研究。
