Document Detail


Results of the phase I food and drug administration clinical trial of duct-occlud device occlusion of patent ductus arteriosus.
MedLine Citation:
PMID:  11146528     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
J W Moore; D DiMeglio; A P Javois; M Takahashi; F Berdjis; J P Cheatham
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Comparative Study; Journal Article; Multicenter Study    
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  52     ISSN:  1522-1946     ISO Abbreviation:  Catheter Cardiovasc Interv     Publication Date:  2001 Jan 
Date Detail:
Created Date:  2001-02-02     Completed Date:  2001-02-22     Revised Date:  2010-04-12    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  74-8     Citation Subset:  IM    
Affiliation:
Heart Center for Children, St. Christopher's Hospital for Children, Philadelphia, PA 19134, USA. jwm32@drexel.edu
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MeSH Terms
Descriptor/Qualifier:
Ductus Arteriosus, Patent / diagnosis,  therapy*
Equipment Design
Equipment Safety
Follow-Up Studies
Heart Catheterization / instrumentation*,  methods
Humans
Patient Selection
Risk Assessment
Treatment Outcome
United States
United States Food and Drug Administration

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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