NIT-OCCLUD PDA Phase II Sentinel Trial

Study Overview
=================
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: To determine the safety of the spiral coil by monitoring and reporting deaths and adverse events associated with the device and device placement. To determine the effectiveness of the spiral coil by evaluating clinical and echocardiographic occlusion rates.

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

Conditions
-----------------
Ductus Arteriosus, Patent

Intervention / Treatment
-----------------
* Device: Transcatheter PDA Coil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PDA with 4 mm or smaller minimum diameter by color Doppler Patent weight > 5 Kg, Age 6 months to 21 years (Patients older than 21 years may have device implant and be included in a study registry.) Previous treatment by surgery or Nit-Occlud device with residual PDA noted at least 6 months after the procedure Angiographic minimum PDA diameter (D1) less than 4 mm. (Patients with angiographic diameters larger than 4 mm and smaller or equal to 5 mm may have device implant and be included in a study registry.) Exclusion Criteria: Associated cardiac anomalies requiring surgery Known bleeding or blood clotting disorders Ongoing febrile illness Pregnancy Pulmonary hypertension/increased pulmonary vascular resistance (>5 Wood Units) Known hypersensitivity to contrast medium

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcatheter PDA Coil<br>Transcatheter occlusion of Patent Ductus Arteriosus (PDA) with the flex and medium Nit-Occlud PDA. | Device: Transcatheter PDA Coil<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Performance Criteria (OPC) Technical Success at Implant |  | One year | 
| Clinical Closure and Echocardiographic Closure at 12 month follow-up |  | One year | 
| Serious Adverse Events and Mortality at 12 months |  | One year | 
| Total Device or Procedure Related Adverse Events |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transcatheter occlusion of patent ductus arteriosus