Adventist Heart and Vascular Institute, Adventist St. Helena Hospital, St. Helena, California.
Bradenton Cardiology Center, Bradenton, Florida.
Catheter Cardiovasc Interv. 2021 Feb 1;97(2):310-316. doi: 10.1002/ccd.29366. Epub 2020 Nov 19.
To determine the safety and effectiveness of a peripheral artery chronic total occlusion (CTO) crossing catheter following failed crossing attempts with standard guidewires.
CTO crossing remains a challenge during peripheral artery interventions.
In this prospective, international, single-arm study, patients with a peripheral artery CTO that was uncrossable with standard guidewires were treated with a crossing catheter (Wingman, Reflow Medical). The primary efficacy endpoint of CTO crossing success was compared to a performance goal of 70.7%. The primary composite safety endpoint (major adverse event [MAE], clinically significant perforation or embolization, or grade C or greater dissection) was assessed over a 30-day follow-up period and compared to a performance goal of 13.0%.
A total of 85 patients were treated using the Wingman catheter for peripheral artery CTO crossing. Key patient characteristics were mean age of 71±9 years, 66% male, and mean lesion length of 188±94 mm in the superficial femoral artery (71%), popliteal artery (15%), or infrapopliteal arteries (14%). Both primary endpoints of the trial were met¾CTO crossing success was 90% (lower confidence limit=82.5%) and 5 primary safety events occurred in 4 (4.8%) patients (upper confidence limit=10.7%). Over 30 days of follow-up, Rutherford score decreased by at least 2 categories in 74% patients; the percentage of patients with normal hemodynamics assessed with the ankle-brachial index increased from 1% to 51%.
Among patients with a CTO that was unable to be crossed with a standard guidewire, the Wingman catheter was able to cross 90% of occlusions with a favorable safety profile.
确定在标准导丝尝试失败后，使用外周动脉慢性完全闭塞（CTO）穿越导管的安全性和有效性。
CTO 穿越仍然是外周动脉介入治疗的挑战。
在这项前瞻性、国际性、单臂研究中，使用穿越导管（Wingman，Reflow Medical）治疗无法用标准导丝穿越的外周动脉 CTO 患者。CTO 穿越成功的主要疗效终点与 70.7%的性能目标进行比较。主要复合安全性终点（主要不良事件 [MAE]、临床显著穿孔或栓塞、或 C 或更高级别的夹层）在 30 天随访期间进行评估，并与 13.0%的性能目标进行比较。
共有 85 名患者使用 Wingman 导管治疗外周动脉 CTO 穿越。关键患者特征为平均年龄 71±9 岁，66%为男性，股浅动脉（71%）、腘动脉（15%）或腘下动脉（14%）的平均病变长度为 188±94mm。试验的两个主要终点均达到了¾CTO 穿越成功率为 90%（置信下限为 82.5%），4 名患者（4.8%）发生 5 例主要安全性事件（置信上限为 10.7%）。在 30 天的随访期间，74%的患者至少 Rutherford 评分降低了 2 级；踝肱指数评估的正常血流动力学患者比例从 1%增加到 51%。
在标准导丝无法穿越的 CTO 患者中，Wingman 导管能够以良好的安全性穿越 90%的闭塞。
