Results of the phase I Food and Drug Administration clinical trial of Duct-Occlud device occlusion of patent ductus arteriosus

The purpose of this study was to evaluate the safety and the efficacy of tr anscatheter patent ductus arteriosus (PDA) occlusion with the Duct-Occlud d evice. Six centers participated in this phase I U.S. Food and Drug Administ ration-approved clinical trial with investigational device exemption. Patie nts with restrictive PDA (less than 4-mm minimum diameter) were eligible fo r the study. Sixty-two patients were enrolled. Forty-eight patients had suc cessful implantation of Duct-Occlud devices. Patient follow-up evaluations were conducted at hospital discharge and after 2 and 12 months. At discharg e and after 1 year, all patients had clinical PDA closure. Closure assessed by color flow Doppler was 55% at discharge, 88% at 2 months, and 94% at 1 year. There were no complications related to implantation or noted in follo w-up evaluations. The Duct-Occlud device is safe and efficacious for the cl osure of small- to moderate-size patent ductus arteriosus. Cathet Cardiovas c Intervent 2001;52:74-78. (C) 2001 Wiley-Liss, Inc.