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Results of the Phase I Food and Drug Administration clinical trial of duct‐occlud device occlusion of patent ductus arteriosus
Author(s) -
Moore John W.,
DiMeglio Doreen,
Javois Alexander P.,
Takahashi Masato,
Berdjis Farhouch,
Cheatham John P.
Publication year - 2001
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/1522-726x(200101)52:1<74::aid-ccd1018>3.0.co;2-f
Subject(s) - medicine , ductus arteriosus , food and drug administration , occlusion , clinical trial , surgery , shunt (medical) , duct (anatomy) , cardiology , environmental health
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. Cathet Cardiovasc Intervent 2001;52:74–78. © 2001 Wiley‐Liss, Inc.