Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
357 participants
INTERVENTIONAL
2002-11-30
2007-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Transcatheter PDA Coil
Transcatheter occlusion of Patent Ductus Arteriosus (PDA) with the flex and medium Nit-Occlud PDA.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Known bleeding or blood clotting disorders
* Ongoing febrile illness
* Pregnancy
* Pulmonary hypertension/increased pulmonary vascular resistance (\>5 Wood Units)
* Known hypersensitivity to contrast medium
6 Months
21 Years
ALL
No
Sponsors
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PFM Medical, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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John W Moore, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Rady Children's Hospital, San Diego, Department of Pediatrics, UCSD, School of Medicine
Locations
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Mattel Children's Hospital at UCLA
Los Angeles, California, United States
Children's Hospital Central California
Madera, California, United States
Children's Hospital of Orange County
Orange, California, United States
A.I. Dupont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Hope Children's Hospital
Oak Lawn, Illinois, United States
Children's Hospital of Illinois
Peoria, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Children's Hospital of Iowa
Iowa City, Iowa, United States
Children's Hospital of Akron
Akron, Ohio, United States
Columbus Children's Hospital
Columbus, Ohio, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Children's Hospital and Regional Medical Center Seattle
Seattle, Washington, United States
Countries
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Other Identifiers
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G010278
Identifier Type: -
Identifier Source: org_study_id
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