NIT-OCCLUD PDA Phase II Sentinel Trial

Ductus Arteriosus, Patent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828334
• Other study ID #: G010278
• Status: Completed
• Phase: N/A
• First received: January 20, 2009
• Last updated: March 21, 2018
• Start date: November 2002
• Est. completion date: October 2007

Study information

• Verified date: March 2018
• Source: PFM Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: October 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital of Akron	Akron	Ohio
United States	Columbus Children's Hospital	Columbus	Ohio
United States	Driscoll Children's Hospital	Corpus Christi	Texas
United States	Children's Medical Center of Dallas	Dallas	Texas
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	Children's Hospital of Iowa	Iowa City	Iowa
United States	Mattel Children's Hospital at UCLA	Los Angeles	California
United States	Children's Hospital Central California	Madera	California
United States	Hope Children's Hospital	Oak Lawn	Illinois
United States	Children's Hospital of Orange County	Orange	California
United States	Children's Hospital of Illinois	Peoria	Illinois
United States	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania
United States	Children's Hospital and Regional Medical Center Seattle	Seattle	Washington
United States	Children's National Medical Center	Washington	District of Columbia
United States	A.I. Dupont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
PFM Medical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Performance Criteria (OPC) Technical Success at Implant		One year
Primary	Clinical Closure and Echocardiographic Closure at 12 month follow-up		One year
Primary	Serious Adverse Events and Mortality at 12 months		One year
Primary	Total Device or Procedure Related Adverse Events		One year
Secondary	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