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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

January 20, 2009
January 23, 2009
March 23, 2018
November 2002
June 2007   (Final data collection date for primary outcome measure)
  • Objective Performance Criteria (OPC) Technical Success at Implant [ Time Frame: One year ]
  • Clinical Closure and Echocardiographic Closure at 12 month follow-up [ Time Frame: One year ]
  • Serious Adverse Events and Mortality at 12 months [ Time Frame: One year ]
  • Total Device or Procedure Related Adverse Events [ Time Frame: One year ]
Not Provided
Complete list of historical versions of study NCT00828334 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
NIT-OCCLUD PDA Phase II Sentinel Trial
Transcatheter Occlusion of Patent Ductus Arteriosus (PDA) With the NIT-OCCLUD PDA Occlusions System
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.

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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ductus Arteriosus, Patent
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.
Experimental: Transcatheter PDA Coil
Transcatheter occlusion of Patent Ductus Arteriosus (PDA) with the flex and medium Nit-Occlud PDA.
Intervention: Device: Transcatheter PDA Coil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
357
Not Provided
October 2007
June 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Months to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00828334
G010278
Yes
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
Plan to Share IPD: Undecided
PFM Medical, Inc
PFM Medical, Inc
Not Provided
Principal Investigator: John W Moore, MD, MPH Rady Children's Hospital, San Diego, Department of Pediatrics, UCSD, School of Medicine
PFM Medical, Inc
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP