
MASCOT (ClinicalTrials.gov NCT 00619788) was a prospective non-randomized European multi-center trial investigating the role of the AngioSculpt PTA Scoring Balloon Catheter for the treatment of severe femoro-popliteal stenotic disease (<= 8 cm in length). Patients with debilitating claudication (severe leg pain on walking) were treated at three pre-eminent European clinical sites with the recently introduced larger and longer AngioSculpt devices. Primary endpoints included safety at 30 days (complication-free survival) and target lesion patency at 12 months, as determined by Duplex ultrasound. The study results demonstrated an excellent safety outcome, with 96% of patients complication-free at 30 days, and a very favorable overall target lesion patency rate of 74.1% at 12 months. The study was conducted at two sites in Belgium and one site in Germany... AngioScore's Press Release -