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NIT-OCCLUD PDA Phase II Sentinel Trial

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ClinicalTrials.gov Identifier: NCT00828334
Recruitment Status : Completed
First Posted : January 23, 2009
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
PFM Medical, Inc

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.

Condition or disease Intervention/treatment Phase
Ductus Arteriosus, Patent Device: Transcatheter PDA Coil Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 357 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcatheter Occlusion of Patent Ductus Arteriosus (PDA) With the NIT-OCCLUD PDA Occlusions System
Study Start Date : November 2002
Actual Primary Completion Date : June 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Transcatheter PDA Coil
Transcatheter occlusion of Patent Ductus Arteriosus (PDA) with the flex and medium Nit-Occlud PDA.
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.



Primary Outcome Measures :
  1. Objective Performance Criteria (OPC) Technical Success at Implant [ Time Frame: One year ]
  2. Clinical Closure and Echocardiographic Closure at 12 month follow-up [ Time Frame: One year ]
  3. Serious Adverse Events and Mortality at 12 months [ Time Frame: One year ]
  4. Total Device or Procedure Related Adverse Events [ Time Frame: One year ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: One year ]


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Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828334


Locations
United States, California
Mattel Children's Hospital at UCLA
Los Angeles, California, United States, 90095
Children's Hospital Central California
Madera, California, United States, 93638
Children's Hospital of Orange County
Orange, California, United States, 92868
United States, Delaware
A.I. Dupont Hospital for Children
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Illinois
Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
Children's Hospital of Illinois
Peoria, Illinois, United States, 61603
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202-5225
United States, Iowa
Children's Hospital of Iowa
Iowa City, Iowa, United States, 52242
United States, Ohio
Children's Hospital of Akron
Akron, Ohio, United States, 44308
Columbus Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
United States, Texas
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Children's Medical Center of Dallas
Dallas, Texas, United States, 75235
United States, Washington
Children's Hospital and Regional Medical Center Seattle
Seattle, Washington, United States, 98105
Sponsors and Collaborators
PFM Medical, Inc
Investigators
Principal Investigator: John W Moore, MD, MPH Rady Children's Hospital, San Diego, Department of Pediatrics, UCSD, School of Medicine

Responsible Party: PFM Medical, Inc
ClinicalTrials.gov Identifier: NCT00828334     History of Changes
Other Study ID Numbers: G010278
First Posted: January 23, 2009    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by PFM Medical, Inc:
transcatheter occlusion of patent ductus arteriosus

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities