Clinical trial NCT00828334: NIT-OCCLUD PDA Phase II Sentinel Trial
Official title: Transcatheter Occlusion of Patent Ductus Arteriosus (PDA) With the NIT-OCCLUD PDA Occlusions System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ductus Arteriosus, Patent
Keywords: transcatheter occlusion of patent ductus arteriosus
Lead sponsor: PFM Medical, Inc
Sponsor class: INDUSTRY
First posted: 2009-01-23
Enrollment: 357
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective Performance Criteria (OPC) Technical Success at Implant
timeFrame: One year
measure: Clinical Closure and Echocardiographic Closure at 12 month follow-up
timeFrame: One year
measure: Serious Adverse Events and Mortality at 12 months
timeFrame: One year
measure: Total Device or Procedure Related Adverse Events
timeFrame: One year
Secondary outcomes:
measure: 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
timeFrame: One year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Mattel Children's Hospital at UCLA
state: California
city: Madera
country: United States
facility: Children's Hospital Central California
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Wilmington
country: United States
facility: A.I. Dupont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Oak Lawn
country: United States
facility: Hope Children's Hospital
state: Illinois
city: Peoria
country: United States
facility: Children's Hospital of Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Iowa City
country: United States
facility: Children's Hospital of Iowa
state: Iowa
city: Akron
country: United States
facility: Children's Hospital of Akron
state: Ohio
city: Columbus
country: United States
facility: Columbus Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children
state: Pennsylvania
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: Dallas
country: United States
facility: Children's Medical Center of Dallas
state: Texas
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center Seattle
state: Washington
Study officials:
affiliation: Rady Children's Hospital, San Diego, Department of Pediatrics, UCSD, School of Medicine
name: John W Moore, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: