Prospective Study of Serration Angioplasty in the Infrapopliteal Arteries Using the Serranator Device: PRELUDE BTK Study

Abstract

A prospective, multicenter, single-arm feasibility study (dates not included). Forty-six patients with limb-threatening ischemia (80%; n = 37) or claudication (20%; n = 9) with 53 “infrapopliteal” artery stenotic (72%) or occluded (28%) lesions underwent treatment with the Serranator device (Cagent Vascular, Wayne, Pa). Device success was 92%. Freedom from major adverse limb events plus death was 96% after 30 days. One lesion (2%) required a bailout stent for dissection. The Rutherford classification score had improved by one or more levels for 70% of the patients, with 42% having a score of 0, at 6 months. Serrations were present in all treated lesions in nine patients who had undergone optical coherence tomography or intravascular ultrasound. Serranator treatment of “infrapopliteal” artery stenoses showed excellent lumen gain with minimal evidence of arterial injury and good clinical results. Imaging studies showed serrations without significant dissection, supporting the device's proposed mechanism of action.