NIT-OCCLUD PDA Phase II Sentinel Trial

March 21, 2018 updated by: PFM Medical, Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

357

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Mattel Children's Hospital at UCLA
      • Madera, California, United States, 93638
        • Children's Hospital Central California
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • A.I. Dupont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Hope Children's Hospital
      • Peoria, Illinois, United States, 61603
        • Children's Hospital of Illinois
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5225
        • Riley Hospital for Children
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Children's Hospital of Iowa
    • Ohio
      • Akron, Ohio, United States, 44308
        • Children's Hospital of Akron
      • Columbus, Ohio, United States, 43205
        • Columbus Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19134
        • St. Christopher's Hospital for Children
    • Texas
      • Corpus Christi, Texas, United States, 78411
        • Driscoll Children's Hospital
      • Dallas, Texas, United States, 75235
        • Children's Medical Center of Dallas
    • Washington
      • Seattle, Washington, United States, 98105
        • Children's Hospital and Regional Medical Center Seattle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Performance Criteria (OPC) Technical Success at Implant
Time Frame: One year
One year
Clinical Closure and Echocardiographic Closure at 12 month follow-up
Time Frame: One year
One year
Serious Adverse Events and Mortality at 12 months
Time Frame: One year
One year
Total Device or Procedure Related Adverse Events
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PFM Medical, Inc

Investigators

  • Principal Investigator: John W Moore, MD, MPH, Rady Children's Hospital, San Diego, Department of Pediatrics, UCSD, School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

January 20, 2009

First Submitted That Met QC Criteria

January 22, 2009

First Posted (ESTIMATE)

January 23, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G010278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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