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

Citation
Jw. Moore et al., Results of the phase I Food and Drug Administration clinical trial of Duct-Occlud device occlusion of patent ductus arteriosus, CATHET C IN, 52(1), 2001, pp. 74-78
Citations number
12
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Cardiovascular & Respiratory Systems
Journal title
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS
ISSN journal
1522-1946 → ACNP
Volume
52
Issue
1
Year of publication
2001
Pages
74 - 78
Database
ISI
SICI code
1522-1946(200101)52:1<74:ROTPIF>2.0.ZU;2-H
Abstract
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.