Walsh Simon, Dudek Dariusz, Bryniarski Leszek, Assali Abid, Danenberg Haim, Lotan Chaim, Hanratty Colm, Wilkołek Piotr, Kornowski Ran
Belfast Health & Social Care Trust, Cardiology, Belfast, Ireland.
J Invasive Cardiol. 2016 Mar;28(3):88-91.
The aim of this first-in-human (FIH) study was to evaluate the efficacy and safety of the novel NovaCross microcatheter system in eligible consecutive patients with chronic total occlusion (CTO).
CTOs remain the most challenging lesion subset in percutaneous coronary intervention (PCI). Failure to cross to the distal true lumen with the guidewire is one of the major causes of procedural failure in CTO-PCI. The NovaCross microcatheter (Nitiloop, Ltd) is designed to improve antegrade recanalization success.
This study was a prospective, non-randomized, FIH investigational study. Patients with total occlusion of a coronary artery determined to be more than 3 months old and accepted for coronary CTO-PCI with an intended antegrade strategy were enrolled.
Twenty-four patients were enrolled in this study. Despite the high complexity of the lesions (including 80% J-CTO score ≥3 and 50% of the cases having had a previous failed CTO-PCI attempt), technical success was 81.8%. No patients reported any major adverse cardiac event up to and including 30 days post procedure.
In this FIH study, the NovaCross microcatheter exhibited the potential to stabilize guidewires and enhance crossing of coronary CTO lesions.
这项首次人体（FIH）研究的目的是评估新型NovaCross微导管系统在符合条件的连续性慢性完全闭塞（CTO）患者中的疗效和安全性。
CTO仍然是经皮冠状动脉介入治疗（PCI）中最具挑战性的病变亚组。导丝未能穿过至远端真腔是CTO-PCI手术失败的主要原因之一。NovaCross微导管（Nitiloop有限公司）旨在提高顺行再通成功率。
本研究是一项前瞻性、非随机、首次人体研究性研究。纳入冠状动脉完全闭塞超过3个月且接受冠状动脉CTO-PCI并采用预期顺行策略的患者。
本研究共纳入24例患者。尽管病变高度复杂（包括80%的J-CTO评分≥3，且50%的病例此前CTO-PCI尝试失败），技术成功率仍为81.8%。直至术后30天，无患者报告任何重大不良心脏事件。
在这项首次人体研究中，NovaCross微导管显示出稳定导丝并增强冠状动脉CTO病变通过能力的潜力。
