Ductus Arteriosus, Patent Clinical Trial
Official title:
Transcatheter Occlusion of Patent Ductus Arteriosus (PDA) With the NIT-OCCLUD PDA Occlusions System
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":
- Nit-Occlud coils, 2 types: flexible (3 sizes) and medium (3 sizes)
- Introducer Sheath, F4 or F5 85cm.
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:
1. To determine the safety of the spiral coil by monitoring and reporting deaths and
adverse events associated with the device and device placement.
2. To determine the effectiveness of the spiral coil by evaluating clinical and
echocardiographic occlusion rates.
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