Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT00828334
Status:
COMPLETED
Last Update Posted:
2018-03-23
First Post:
2009-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NIT-OCCLUD PDA Phase II Sentinel Trial
Sponsor:
PFM Medical, Inc
Organization:
Study Overview
Official Title:
Transcatheter Occlusion of Patent Ductus Arteriosus (PDA) With the NIT-OCCLUD PDA Occlusions System
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: