An interventional study of Transcatheter PDA Coil in Ductus Arteriosus, Patent, sponsored by PFM Medical, Inc. Completed at 15 sites in United States. Open to participants aged 6 Months to 21 Years. Per ClinicalTrials.gov, last updated 2018-03-23.
Sponsored by PFM Medical, Inc · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of the Nit-Occlud -PDA Occlusion System for transcatheter closure of PDA with minimum angiographic diameter less than 4 mm, and to compare one year safety and efficacy outcomes with recommended OPCs.
The purpose of this clinical investigation is to evaluate whether transcatheter occlusion of PDAs with a minimum vessel diameter of 4 mm or smaller, by means of permanent implantation of the Nit-Occlud Spiral Coil for PDA Occlusion, is safe and effective.
The device used for this purpose is a set of two items named "Nit-Occlud - PDA Occlusion System":
The intended use of the device is the percutaneous, transluminal closure of PDA with an internal diameter or 4mm and smaller in patients who comply with the selection criteria.
The investigation will continue until the sponsor receives FDA approval for commercial distribution and implantation of the system, or until the project is terminated by the sponsor or by the investigators.
The objectives of this study are:
144 studies on the registry are indexed under Ductus Arteriosus, Patent; 17 are open to participants now.
This study's enrollment of 357 is above the median of 80 across 81 interventional studies indexed under Ductus Arteriosus, Patent.
Browse Ductus Arteriosus, Patent studies →PFM Medical, Inc is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Transcatheter occlusion of Patent Ductus Arteriosus (PDA) with the flex and medium Nit-Occlud PDA.
Device: Transcatheter PDA Coil
The Nit-Occlud PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter \< 4 mm.
Objective Performance Criteria (OPC) Technical Success at Implant
Time frame: One year
Clinical Closure and Echocardiographic Closure at 12 month follow-up
Time frame: One year
Serious Adverse Events and Mortality at 12 months
Time frame: One year
Total Device or Procedure Related Adverse Events
Time frame: One year
Composite Success. That is technical success, clinical and echocardiographic closure, and absence of device or procedure related death or serious AE at 12 months follow-up
Time frame: One year
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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PFM Medical, Inc