Recoil Study

Serration Angioplasty Is Associated With Less Recoil in Infrapopliteal Arteries Compared With Plain Balloon Angioplasty

Methods: This multi-center, sequential comparative study included patients with de novo or restenotic lesions of infrapopliteal arteries up to 22 cm in length. Patients were enrolled sequentially and underwent alternating POBA or serration angioplasty with Serranator. The study captured angiographic imaging at pre, immediately post, and 15-minute after angioplasty. Vessel recoil, final diameter stenosis, and dissection were compared using core laboratory analysis.

Results: This study enrolled 36 patients who underwent treatment of 39 infrapopliteal lesions. There was no significant difference between Serranator (n=20) and POBA (n=19) with respect to baseline demographics and lesion characteristics. Clinically relevant recoil (>30%) was present after serration angioplasty in 10% of patients and after POBA in 53% (p=0.01). Serration angioplasty produces substantially less arterial recoil compared with POBA.