NIT-OCCLUD PDA Phase II Sentinel Trial
Transcatheter Occlusion of Patent Ductus Arteriosus (PDA) With the NIT-OCCLUD PDA Occlusions System
1 other identifier
interventional
357
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2002
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 20, 2009
CompletedFirst Posted
Study publicly available on registry
January 23, 2009
CompletedMarch 23, 2018
March 1, 2018
4.6 years
January 20, 2009
March 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Objective Performance Criteria (OPC) Technical Success at Implant
One year
Clinical Closure and Echocardiographic Closure at 12 month follow-up
One year
Serious Adverse Events and Mortality at 12 months
One year
Total Device or Procedure Related Adverse Events
One year
Secondary Outcomes (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
One year
Study Arms (1)
Transcatheter PDA Coil
EXPERIMENTALTranscatheter occlusion of Patent Ductus Arteriosus (PDA) with the flex and medium Nit-Occlud PDA.
Interventions
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
You may qualify if:
- 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.)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PFM Medical, Inclead
Study Sites (15)
Mattel Children's Hospital at UCLA
Los Angeles, California, 90095, United States
Children's Hospital Central California
Madera, California, 93638, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
A.I. Dupont Hospital for Children
Wilmington, Delaware, 19899, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Hope Children's Hospital
Oak Lawn, Illinois, 60453, United States
Children's Hospital of Illinois
Peoria, Illinois, 61603, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202-5225, United States
Children's Hospital of Iowa
Iowa City, Iowa, 52242, United States
Children's Hospital of Akron
Akron, Ohio, 44308, United States
Columbus Children's Hospital
Columbus, Ohio, 43205, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
Children's Medical Center of Dallas
Dallas, Texas, 75235, United States
Children's Hospital and Regional Medical Center Seattle
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John W Moore, MD, MPH
Rady Children's Hospital, San Diego, Department of Pediatrics, UCSD, School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2009
First Posted
January 23, 2009
Study Start
November 1, 2002
Primary Completion
June 1, 2007
Study Completion
October 1, 2007
Last Updated
March 23, 2018
Record last verified: 2018-03