Tomasello Alejandro, Gramegna Laura Ludovica, Vega Pedro, Castaño Carlos, Moreu Manuel, Dominguez Carlos, Macho Juan
Interventional Neuroradiology Section, Vall d Hebron University Hospital, Barcelona, Spain.
Vall d'Hebron Research Institute, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Interv Neuroradiol. 2023 Oct 17:15910199231207407. doi: 10.1177/15910199231207407.
The iNedit balloon distal access catheter is a novel thrombectomy device. It has an inner diameter of 0.058″, proximal outer diameter of 2.13 mm, and distal outer diameter of 1.67mm. It is compatible with a 0.088″ guide catheter and includes a balloon located 5 cm from the catheter tip, enabling proximal flow restriction and combined therapy with stent retrievers. We investigate the appraisal of the use, safety, and efficacy of the iNedit catheter in the first-in-human study.
In the preliminary cases that demanded training on the product previous to a multicentric study, prospective data were collected on 22 consecutive patients treated with the iNedit catheter to perform thrombectomy for acute ischemic stroke due to large vessel occlusion within 24 h. The outcome measures consisted of several evaluations of user experience rated on a 5-point scale ranging from 1 (bad) to 5 (excellent), as well as assessments of procedural safety outcomes such as artery perforation and arterial occlusion, procedural efficacy outcomes including first-pass effect (Thrombolysis In Cerebral Infarction [TICI] 2c/3) and final recanalization (TICI 2b/3), and clinical efficacy outcomes such as a 3-month 0-2 modified Rankin Scale (mRS).
The mean age was 72 ± 12 years old; median National Institute Health Stroke Scale was 17 (11-19). Sites of primary occlusion were: 2 internal carotid artery, 12 M1-MCA, 7 M2-MCA, and one P1. Median score evaluation of the appraisal of use was 4- IQR [4-5]. The median number of passes was 1 [IQR 1-2]. First pass complete recanalization rate was 50% and the final recanalization rate was 94.45%. No artery perforation and arterial occlusion. Good functional outcome mRS 0-2 was achieved in 50% of patients.
In this initial clinical experience, iNedit device achieved a high rate of first-pass effect and final recanalization rate with no safety concerns, thus favoring a high percentage of good clinical outcomes.
iNedit球囊远端通路导管是一种新型血栓切除术器械。其内径为0.058英寸，近端外径为2.13毫米，远端外径为1.67毫米。它与0.088英寸的引导导管兼容，并包括一个位于距导管尖端5厘米处的球囊，可实现近端血流限制并与支架取栓器联合治疗。我们在首次人体研究中调查了iNedit导管的使用、安全性和有效性评估。
在多中心研究之前需要对产品进行培训的初步病例中，收集了连续22例接受iNedit导管治疗的患者的前瞻性数据，这些患者在24小时内因大血管闭塞而发生急性缺血性卒中并接受血栓切除术。结果测量包括对用户体验的几项评估，评分范围为1（差）至5（优秀）的5分制，以及对手术安全性结果（如动脉穿孔和动脉闭塞）、手术有效性结果（包括首次通过效果[脑梗死溶栓（TICI）2c/3]和最终再通[TICI 2b/3]）以及临床有效性结果（如3个月时0-2改良Rankin量表[mRS]）的评估。
平均年龄为72±12岁；美国国立卫生研究院卒中量表中位数为17（11-19）。主要闭塞部位为：2例颈内动脉、12例M1-MCA、7例M2-MCA和1例P1。使用评估的中位数评分为4 - 四分位数间距[4-5]。通过次数的中位数为1[四分位数间距1-2]。首次通过完全再通率为50%，最终再通率为94.45%。无动脉穿孔和动脉闭塞。50%的患者获得了良好的功能结局mRS 0-2。
在这一初步临床经验中，iNedit器械实现了较高的首次通过效果和最终再通率，且无安全问题，因此有利于获得较高比例的良好临床结局。
