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.

Advances in Revascularization for Peripheral Artery Disease: Revascularization in PAD

“…The combination of these tools has significantly improved the technical success in crossing lower extremity arterial occlusions. [113][114][115][116][117][118][119] Thombectomy/Thrombolysis Tools Long segment occlusions, especially those involving the superficial femoral artery, are comprised of atherosclerotic plaque and thrombus. In addition, acute or subacute presentations of lower extremity occlusive disease may have acute thrombosis superimposed upon chronic occlusive disease.…”

“…The combination of these tools has significantly improved the technical success in crossing lower extremity arterial occlusions. 113–119…”

Another promising device for peripheral CTO's: But what about long‐term patency

“…An example of the mechanical approach to breeching the proximal cap is the Wingman catheter. In this study, it was 90% successful in crossing the CTO lesions that were previously uncrossable with conventional methods 3 . This successful study warrants a larger study group with a longer follow‐up.…”

First Experience With The GoBack-Catheter For Successful Crossing of Complex Chronic Total Occlusions in Lower Limb Arteries

“…Recently, first results using the Wingman catheter (Reflow Medical, San Clemente, CA, USA), which shows some similar features to the GoBack-catheter, have been published. 17 It is a 4Fr. compatible, robust catheter with a pushable and retractable needle at the tip.…”