Results of the phase I food and drug administration clinical trial of duct-occlud device occlusion of patent ductus arteriosus.

ABSTRACT

The purpose of this study was to evaluate the safety and the efficacy of transcatheter patent ductus arteriosus (PDA) occlusion with the Duct-Occlud device. Six centers participated in this phase I U.S. Food and Drug Administration-approved clinical trial with investigational device exemption. Patients with restrictive PDA (less than 4-mm minimum diameter) were eligible for the study. Sixty-two patients were enrolled. Forty-eight patients had successful implantation of Duct-Occlud devices. Patient follow-up evaluations were conducted at hospital discharge and after 2 and 12 months. At discharge 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 follow-up evaluations. The Duct-Occlud device is safe and efficacious for the closure of small- to moderate-size patent ductus arteriosus.