A multicenter experience evaluating chronic total occlusion crossing with the Wildcat catheter (the CONNECT study).

OBJECTIVE

Percutaneous techniques for crossing femoropopliteal chronic total occlusions (CTOs) offer an alternative to bypass surgery in patients deemed to be at increased risk due to advanced age or comorbidities. Recent reports document good success rates in catheters designed to reconstitute peripherally occluded arteries following failed guidewire passage. The Wildcat catheter (Avinger, Redwood City, Calif) is a novel device with a rotating distal tip and deployable wedges fashioned for channeling a passage through arterial occlusions. This report describes the results of a prospective, multicenter, nonrandomized trial evaluating the safety and efficacy of the Wildcat device when crossing de novo or restenotic femoropopliteal CTOs.

METHODS

Between August 2010 and April 2011, patients with peripheral arterial disease due to a femoropopliteal CTO>1 cm and ≤35 cm were evaluated for study enrollment at 15 U.S. sites. During treatment, the physician initially attempted to cross the CTO using conventional guidewires per protocol; if the guidewire successfully crossed, the patient was considered a screen failure and the Wildcat was not deployed. At 30 days, patients were reevaluated. The primary efficacy end point was successful crossing of the Wildcat into the distal true lumen as confirmed by angiography. Primary safety end points included no in-hospital or 30-day major adverse events, no clinically significant perforation or embolization, and no grade C or greater dissection. Additional data collected included lesion length, degree of calcification, and location.

RESULTS

Eighty-eight patients were enrolled in the trial. Of these, the Wildcat device was used in 84 patients (95%) per protocol. Successful CTO crossing was reported and confirmed by independent review in 89% (75/84) of cases with 5% (4/84) major adverse events as defined in the protocol (predominantly perforations sealed with balloon inflation). There were no clinically relevant events associated with any of the perforations. The mean CTO length was 174±96 mm (range, 15-350 mm). Approximately 57% (n=48) of all lesions were categorized as containing at least moderate calcification. Eighty-nine percent (n=75) of vessels recanalized were superficial femoral arteries.

CONCLUSIONS

In this multicenter study, the Wildcat catheter demonstrated an 89% crossing success rate with little associated morbidity. The Wildcat catheter is a viable device for crossing moderately calcified femoropopliteal CTOs.