Performance of the Wingman catheter in peripheral artery chronic total occlusions: Short-term results from the international Wing-It trial

Abstract

Objectives: To determine the safety and effectiveness of a peripheral artery chronic total occlusion (CTO) crossing catheter following failed crossing attempts with standard guidewires.

Background: CTO crossing remains a challenge during peripheral artery interventions.

Methods: 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%.

Results: 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%.

Conclusions: 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.

Keywords: atherosclerosis; catheter design; critical; limb ischemia; peripheral arterial disease.

FIGURE 1

The Wingman crossing catheter, an over‐the‐wire crossing catheter available in 0.014‐, 0.018‐, and 0.035‐in. configurations and a working length up to 150 cm that utilizes an extendable beveled tip for chronic total occlusion penetration [Color figure can be viewed at wileyonlinelibrary.com]

FIGURE 2

A 65‐year‐old female was treated for a popliteal artery (P2) chronic total occlusion (located between P2 and TPT, left panel). After failure to cross with a standard guidewire, the Wingman catheter successfully crossed the occlusion (arrow, middle panel) and facilitated endovascular treatment with balloon angioplasty resulting in 17% final diameter stenosis (right panel)

FIGURE 3

Change in Rutherford classification from pretreatment to 30 days after endovascular therapy for peripheral artery chronic total occlusion facilitated by the Wingman crossing catheter [Color figure can be viewed at wileyonlinelibrary.com]