| Results of the phase I food and drug administration clinical trial of duct-occlud device occlusion of patent ductus arteriosus. | |
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MedLine Citation:
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PMID: 11146528 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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J W Moore; D DiMeglio; A P Javois; M Takahashi; F Berdjis; J P Cheatham |
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Publication Detail:
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Type: Clinical Trial; Clinical Trial, Phase I; Comparative Study; Journal Article; Multicenter Study |
Journal Detail:
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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:
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Created Date: 2001-02-02 Completed Date: 2001-02-22 Revised Date: 2010-04-12 |
Medline Journal Info:
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Nlm Unique ID: 100884139 Medline TA: Catheter Cardiovasc Interv Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 74-8 Citation Subset: IM |
Affiliation:
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Heart Center for Children, St. Christopher's Hospital for Children, Philadelphia, PA 19134, USA. jwm32@drexel.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Ductus Arteriosus, Patent
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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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