NCT00828334

NIT-OCCLUD PDA Phase II Sentinel Trial

Transcatheter Occlusion of Patent Ductus Arteriosus (PDA) With the NIT-OCCLUD PDA Occlusions System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: PFM Medical, Inc · Industry
• Sex: All
• Age: 6 Months – 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ductus Arteriosus, Patent

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2002-11-01
• Primary completion: 2007-06-01
• Completion: 2007-10-01
• First posted: 2009-01-23
• Last updated: 2018-03-23

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study