TRANSCEND Pivotal Trial 12-month Results TRIAL OVERVIEW PRINCIPAL INVESTIGATORSMarianne Brodmann,
MDWilliam Gray, MDKenneth Rosenfield, MDTRIAL DESIGN, BIOSTATISTICS, DSMB, CECBaim Institute TRIAL OPERATIONS Medpass (OUS); Clinlogix (US) Prospective, multicenter, international, randomized, single-blind trial of Surveil DCB versus IN.PACT
Admiral DCB (1:1)446 subjects randomized52 US sites (N=290) and 13 OUS sites (N=156)Surveil (N=222) and IN.PACT ADMIRAL (N=224)60-month follow-upIndependent and blinded: DUS Core Lab, Angiographic Core Lab, Clinical Events Committee;
unblinded Data Monitoring CommitteeHypotheses test - Non inferiority (15% NI margin for efficacy; 10% for safety) Global Site Participation CAUTION: SurVeil™
Drug-Coated Balloon is an investigational device. Limited by Federal (or United States) law to investigational use.